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

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
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-stage-ivc-major-salivary-gland-cancer-ajcc-v7
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: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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

release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
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

release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
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

release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
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
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
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

release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v7
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
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direction quote
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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
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reviewed at
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created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice