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NCT01806675 · STUDY IN CONTEXT

18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Maximum standard uptake values (SUVmax) were assessed on the basis of position emission tomography (PET) scans using radiotracers 18F-FPPRGD2 and 18F-FDG at baseline and at regular medical care follow-up (6 to 12 weeks after initiation of treatment). The outcome is assessed as the difference in the maximum standard uptake values (SUVmax) values from baseline to follow-up for the 2 radiotracers, and will be reported for each disease type as the median with standard deviation.

Some participants did not contribute some or all post-treatment scans.

→

secondary · POSTED

The treatment effect for participants with glioblastoma multiforme was to be assessed on the basis of post-treatment evaluation per the Response Assessment in Neuro-Oncology (RANO) Criteria. The outcome was the number \& proportion of participants that achieved either a complete response (CR) or partial response (PR), a number without dispersion. RANO criteria are: CR= No T1 gadolinium (T1-G); T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR) stable/decreased, no new lesions; no corticosteroids; clinical condition improved/stable. PR= ≥50% decrease in T1-G; T2/FLAIR decreased/stable ; no new lesions; decreased/stable corticosteroids; clinical condition improved/stable. Stable disease (SD)= \<50% decrease, but more than 25% increase, in T1-G; T2/FLAIR decreased/stable; no new lesions; decreased/stable corticosteroids; clinical condition improved/stable. Progressive disease (PD)= ≥25%increase T1-G; T2/FLAIR increased; increased corticosteroids; clinical condition decreased

This assessment was restricted to glioblastoma multiforme (GBM) participants only, however, no response assessments were obtained for GBM participants.

→

secondary · POSTED

The treatment effect for participants with gynecological cancers (GYN) and renal cell carcinoma (RCC) was assessed on the basis of change in tumor size as determined by pre- and post-treatment CT scans. The outcome is reported as the difference at treatment follow-up, reported as the median with standard deviation.

This assessment was restricted to gynecological cancers and renal cell carcinoma participants only. Tumor response data was not available for all participants in these groups.

→

secondary · POSTED

Tumor Response Rate by EORTC Criteria Tumor response rates were assessed from position emission tomography (PET) scans using 18F-FPPRGD2 \& 18F-FDG at baseline \& after 6 weeks of treatment, per European Organization for Research \& Treatment of Cancer (EORTC) response criteria. The outcome is reported for each radiotracer by disease group as the number of participants achieving complete response (CR), partial response (PR), stable disease (SD), \& progressive disease (PD). * CR= complete resolution of 18F-FDG uptake tumor volume * PR= reduction of 15-25% in tumor 18F-FDG SUVmax after 1 cycle of chemotherapy, and ≥25% after \>1 cycle * SD= increase in tumor 18F-FDG SUVmax of \<25% or a decrease of \<15% \& no increase in 18F-FDG tumor uptake \[\>20% in the longest dimension (LD)\]; * PD= increase in 18F-FDG tumor SUVmax of \>25% in tumor region on baseline; increase in extent of 18F-FDG tumor uptake (\>20% in LD); appearance of new 18F-FDG uptake in metastatic lesions

This assessment was restricted to gynecological cancers and renal cell carcinoma participants only. Tumor response data was not available for all participants in these groups.

→

secondary · POSTED

Progression-free survival (PFS) was defined as remaining alive at 1 year with disease progression, according to the physician's assessment of clinical status, by disease group.

Data was not collected for progression-free survival (PFS).

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

EORTC QLQ · Tumor Response Rate by EORTC Criteria

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01806675
qol key
qol-0003
source section id
NCT01806675-om-0003
source outcome index
3
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Tumor Response Rate by EORTC Criteria
measure definition
Tumor Response Rate by EORTC Criteria Tumor response rates were assessed from position emission tomography (PET) scans using 18F-FPPRGD2 \& 18F-FDG at baseline \& after 6 weeks of treatment, per European Organization for Research \& Treatment of Cancer (EORTC) response criteria. The outcome is reported for each radiotracer by disease group as the number of participants achieving complete response (CR), partial response (PR), stable disease (SD), \& progressive disease (PD). * CR= complete resolution of 18F-FDG uptake tumor volume * PR= reduction of 15-25% in tumor 18F-FDG SUVmax after 1 cycle of chemotherapy, and ≥25% after \>1 cycle * SD= increase in tumor 18F-FDG SUVmax of \<25% or a decrease of \<15% \& no increase in 18F-FDG tumor uptake \[\>20% in the longest dimension (LD)\]; * PD= increase in 18F-FDG tumor SUVmax of \>25% in tumor region on baseline; increase in extent of 18F-FDG tumor uptake (\>20% in LD); appearance of new 18F-FDG uptake in metastatic lesions
time frame
At baseline and 6 weeks
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
This assessment was restricted to gynecological cancers and renal cell carcinoma participants only. Tumor response data was not available for all participants in these groups.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-docetaxel-62c51296
nct id
NCT01806675
trial label
18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy
applicability
unclear
applicability note
Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
5
harms Count
3
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01806675
    outcome key
    om-0000
    source section id
    NCT01806675-om-0000
    source outcome index
    0
    endpoint
    Change From Baseline in Maximum Standard Uptake Values (SUVmax)
    endpoint definition
    Maximum standard uptake values (SUVmax) were assessed on the basis of position emission tomography (PET) scans using radiotracers 18F-FPPRGD2 and 18F-FDG at baseline and at regular medical care follow-up (6 to 12 weeks after initiation of treatment). The outcome is assessed as the difference in the maximum standard uptake values (SUVmax) values from baseline to follow-up for the 2 radiotracers, and will be reported for each disease type as the median with standard deviation.
    time origin
    At baseline and 6 weeks
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Some participants did not contribute some or all post-treatment scans.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01806675
    outcome key
    om-0001
    source section id
    NCT01806675-om-0001
    source outcome index
    1
    endpoint
    Response Assessment by RANO Criteria
    endpoint definition
    The treatment effect for participants with glioblastoma multiforme was to be assessed on the basis of post-treatment evaluation per the Response Assessment in Neuro-Oncology (RANO) Criteria. The outcome was the number \& proportion of participants that achieved either a complete response (CR) or partial response (PR), a number without dispersion. RANO criteria are: CR= No T1 gadolinium (T1-G); T2-weighted-Fluid-Attenuated Inversion Recovery (T2/FLAIR) stable/decreased, no new lesions; no corticosteroids; clinical condition improved/stable. PR= ≥50% decrease in T1-G; T2/FLAIR decreased/stable ; no new lesions; decreased/stable corticosteroids; clinical condition improved/stable. Stable disease (SD)= \<50% decrease, but more than 25% increase, in T1-G; T2/FLAIR decreased/stable; no new lesions; decreased/stable corticosteroids; clinical condition improved/stable. Progressive disease (PD)= ≥25%increase T1-G; T2/FLAIR increased; increased corticosteroids; clinical condition decreased
    time origin
    At baseline and 6 weeks
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    This assessment was restricted to glioblastoma multiforme (GBM) participants only, however, no response assessments were obtained for GBM participants.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01806675
    outcome key
    om-0002
    source section id
    NCT01806675-om-0002
    source outcome index
    2
    endpoint
    Change in Tumor Size
    endpoint definition
    The treatment effect for participants with gynecological cancers (GYN) and renal cell carcinoma (RCC) was assessed on the basis of change in tumor size as determined by pre- and post-treatment CT scans. The outcome is reported as the difference at treatment follow-up, reported as the median with standard deviation.
    time origin
    9 to 12 weeks
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    This assessment was restricted to gynecological cancers and renal cell carcinoma participants only. Tumor response data was not available for all participants in these groups.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01806675
    outcome key
    om-0003
    source section id
    NCT01806675-om-0003
    source outcome index
    3
    endpoint
    Tumor Response Rate by EORTC Criteria
    endpoint definition
    Tumor Response Rate by EORTC Criteria Tumor response rates were assessed from position emission tomography (PET) scans using 18F-FPPRGD2 \& 18F-FDG at baseline \& after 6 weeks of treatment, per European Organization for Research \& Treatment of Cancer (EORTC) response criteria. The outcome is reported for each radiotracer by disease group as the number of participants achieving complete response (CR), partial response (PR), stable disease (SD), \& progressive disease (PD). * CR= complete resolution of 18F-FDG uptake tumor volume * PR= reduction of 15-25% in tumor 18F-FDG SUVmax after 1 cycle of chemotherapy, and ≥25% after \>1 cycle * SD= increase in tumor 18F-FDG SUVmax of \<25% or a decrease of \<15% \& no increase in 18F-FDG tumor uptake \[\>20% in the longest dimension (LD)\]; * PD= increase in 18F-FDG tumor SUVmax of \>25% in tumor region on baseline; increase in extent of 18F-FDG tumor uptake (\>20% in LD); appearance of new 18F-FDG uptake in metastatic lesions
    time origin
    At baseline and 6 weeks
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    This assessment was restricted to gynecological cancers and renal cell carcinoma participants only. Tumor response data was not available for all participants in these groups.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01806675
    outcome key
    om-0004
    source section id
    NCT01806675-om-0004
    source outcome index
    4
    endpoint
    Progression-free Survival (PFS)
    endpoint definition
    Progression-free survival (PFS) was defined as remaining alive at 1 year with disease progression, according to the physician's assessment of clinical status, by disease group.
    time origin
    1 year
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Data was not collected for progression-free survival (PFS).
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01806675
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Glioblastoma Multiforme (GBM)
    regimen
    Patients with glioblastoma multiforme (GBM) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and 6 weeks (or standard of care follow-up) 18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan 18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2.
    analyzed count
    8
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01806675-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01806675
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Gynecological Cancers
    regimen
    Patients with gynecological cancer undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up) 18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan 18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2.
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01806675-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01806675
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Renal Cell Cancer (RCC)
    regimen
    Patients with renal cell cancer (RCC) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up) 18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan 18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2.
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01806675-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01806675
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Glioblastoma Multiforme (GBM)
    regimen
    Patients with glioblastoma multiforme (GBM) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and 6 weeks (or standard of care follow-up) 18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan 18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01806675-om-0001#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01806675
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Gynecological Cancers
    regimen
    Patients with gynecological cancer undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up) 18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan 18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01806675-om-0001#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01806675
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Renal Cell Cancer (RCC)
    regimen
    Patients with renal cell cancer (RCC) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up) 18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan 18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01806675-om-0001#groups/OG002
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01806675
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Glioblastoma Multiforme (GBM)
    regimen
    Patients with glioblastoma multiforme (GBM) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and 6 weeks (or standard of care follow-up) 18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan 18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01806675-om-0002#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01806675
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Gynecological Cancers
    regimen
    Patients with gynecological cancer undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up) 18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan 18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01806675-om-0002#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01806675
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Renal Cell Cancer (RCC)
    regimen
    Patients with renal cell cancer (RCC) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up) 18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan 18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01806675-om-0002#groups/OG002
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01806675
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Glioblastoma Multiforme (GBM)
    regimen
    Patients with glioblastoma multiforme (GBM) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and 6 weeks (or standard of care follow-up) 18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan 18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01806675-om-0003#groups/OG000
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01806675
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Gynecological Cancers
    regimen
    Patients with gynecological cancer undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up) 18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan 18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2.
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01806675-om-0003#groups/OG001
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01806675
    outcome key
    om-0003
    arm key
    OG002
    arm label
    Renal Cell Cancer (RCC)
    regimen
    Patients with renal cell cancer (RCC) undergo 18F-FDG and 18F-FPPRGD2 positron emission tomography / computed tomography (PET/CT) imaging at baseline and at 9 t0 12 weeks (or standard of care follow-up) 18F-fludeoxyglucose (18F-FDG): 18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan 18F-FPPRGD2: 18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2.
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01806675-om-0003#groups/OG002
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01806675
    harm key
    EG000
    source section id
    NCT01806675-ae
    event group key
    EG000
    event group label
    Glioblastoma Multiforme (GBM)
    serious affected
    1
    serious at risk
    11
    other affected
    0
    other at risk
    11
    frequency threshold
    0
    collection period
    6 weeks
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01806675
    harm key
    EG001
    source section id
    NCT01806675-ae
    event group key
    EG001
    event group label
    Gynecological Cancers
    serious affected
    0
    serious at risk
    6
    other affected
    0
    other at risk
    6
    frequency threshold
    0
    collection period
    6 weeks
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01806675
    harm key
    EG002
    source section id
    NCT01806675-ae
    event group key
    EG002
    event group label
    Renal Cell Cancer (RCC)
    serious affected
    2
    serious at risk
    8
    other affected
    0
    other at risk
    8
    frequency threshold
    0
    collection period
    6 weeks
    event definition
    Source null
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-docetaxel-62c51296
    nct id
    NCT01806675
    qol key
    qol-0003
    source section id
    NCT01806675-om-0003
    source outcome index
    3
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Tumor Response Rate by EORTC Criteria
    measure definition
    Tumor Response Rate by EORTC Criteria Tumor response rates were assessed from position emission tomography (PET) scans using 18F-FPPRGD2 \& 18F-FDG at baseline \& after 6 weeks of treatment, per European Organization for Research \& Treatment of Cancer (EORTC) response criteria. The outcome is reported for each radiotracer by disease group as the number of participants achieving complete response (CR), partial response (PR), stable disease (SD), \& progressive disease (PD). * CR= complete resolution of 18F-FDG uptake tumor volume * PR= reduction of 15-25% in tumor 18F-FDG SUVmax after 1 cycle of chemotherapy, and ≥25% after \>1 cycle * SD= increase in tumor 18F-FDG SUVmax of \<25% or a decrease of \<15% \& no increase in 18F-FDG tumor uptake \[\>20% in the longest dimension (LD)\]; * PD= increase in 18F-FDG tumor SUVmax of \>25% in tumor region on baseline; increase in extent of 18F-FDG tumor uptake (\>20% in LD); appearance of new 18F-FDG uptake in metastatic lesions
    time frame
    At baseline and 6 weeks
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    This assessment was restricted to gynecological cancers and renal cell carcinoma participants only. Tumor response data was not available for all participants in these groups.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice