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NCT01806675 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2019-10-03

The purpose of the study is to conduct research of a new PET radiopharmaceutical in cancer patients. The uptake of the novel radiopharmaceutical 18F-FPPRGD2 will be assessed in study participants with glioblastoma multiforme (GBM), gynecological cancers, and renal cell carcinoma (RCC) who are receiving antiangiogenesis treatment.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Change From Baseline in Maximum Standard Uptake Values (SUVmax)

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outcome · POSTED

Response Assessment by RANO Criteria

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outcome · POSTED

Change in Tumor Size

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outcome · POSTED

Tumor Response Rate by EORTC Criteria

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outcome · POSTED

Progression-free Survival (PFS)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Provides written informed consent * Diagnosed with advanced NSCLC, breast cancer, GBM or other cancers (such as head and neck, colorectal, pancreatic, renal cancers); patients will undergo anti-angiogenesis treatment or treatment with other drugs that may alter angiogenesis * Able to remain still for duration of each imaging procedure (about one hour) Exclusion Criteria: * Pregnant or nursing * Contraindication to MRI * History of renal insufficiency (only for MRI contrast administration)
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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)
    intervention Names
    1. Drug: 18F-fludeoxyglucose (18F-FDG)
    2. Drug: 18F-FPPRGD2
    label
    Glioblastoma Multiforme (GBM)
    type
    EXPERIMENTAL
  2. description
    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)
    intervention Names
    1. Drug: 18F-fludeoxyglucose (18F-FDG)
    2. Drug: 18F-FPPRGD2
    label
    Gynecological Cancers
    type
    EXPERIMENTAL
  3. description
    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)
    intervention Names
    1. Drug: 18F-fludeoxyglucose (18F-FDG)
    2. Drug: 18F-FPPRGD2
    label
    Renal Cell Cancer (RCC)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Glioblastoma Multiforme (GBM)
    2. Gynecological Cancers
    3. Renal Cell Cancer (RCC)
    description
    18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan
    name
    18F-fludeoxyglucose (18F-FDG)
    other Names
    1. Fludeoxyglucose F-18
    2. 18-FDG
    3. FDG
    type
    DRUG
  2. arm Group Labels
    1. Glioblastoma Multiforme (GBM)
    2. Gynecological Cancers
    3. Renal Cell Cancer (RCC)
    description
    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.
    name
    18F-FPPRGD2
    other Names
    1. (18F)-2-fluoropropionyl-labeled PEGylated dimeric arginine-glycine-aspartic acid peptide
    2. [PEG3-E{c(RGDyk)}2]
    3. fluorine-18-FPPRGD2
    4. [18F]-FPPRGD2
    5. 2-fluoropropionyl-labeled pegylated dimeric RGD peptide
    6. 104150
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
masking Description
All human subject participants were to be evaluated with both 18F-FPPRGD2 PET/CT and 18-FDG PET/CT imaging scans.
primary Purpose
DIAGNOSTIC
Enrollment
count
25
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Change From Baseline in Maximum Standard Uptake Values (SUVmax)
    time Frame
    At baseline and 6 weeks
secondary Outcomes
  1. description
    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
    measure
    Response Assessment by RANO Criteria
    time Frame
    At baseline and 6 weeks
  2. description
    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.
    measure
    Change in Tumor Size
    time Frame
    9 to 12 weeks
  3. description
    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
    measure
    Tumor Response Rate by EORTC Criteria
    time Frame
    At baseline and 6 weeks
  4. description
    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.
    measure
    Progression-free Survival (PFS)
    time Frame
    1 year
Full study description
brief Summary
The purpose of the study is to conduct research of a new PET radiopharmaceutical in cancer patients. The uptake of the novel radiopharmaceutical 18F-FPPRGD2 will be assessed in study participants with glioblastoma multiforme (GBM), gynecological cancers, and renal cell carcinoma (RCC) who are receiving antiangiogenesis treatment.
detailed Description
PRIMARY OBJECTIVE • Evaluate 18F-FPPRGD2 and 18F-FDG as PET/CT or PET/MRI radiotracers for imaging prediction and assessment of response to anti-angiogenesis therapy in participants with glioblastoma multiforme (GBM), gynecological cancers, and renal cell carcinoma (RCC). SECONDARY OBJECTIVE • Progression-free survival (PFS) at up to 1 year after initial scans and treatment OUTLINE: Patients undergo 18F-FPPRGD2 and 18F-FDG PET/CT or PET/MRI medical imaging at baseline and at regular medical care follow-up (6 to 12 weeks). After completion of study imaging, patients are followed up at 12 months.
Source references
references
  1. citation
    Minamimoto R, Jamali M, Barkhodari A, Mosci C, Mittra E, Shen B, Chin F, Gambhir SS, Iagaru A. Biodistribution of the (1)(8)F-FPPRGD(2) PET radiopharmaceutical in cancer patients: an atlas of SUV measurements. Eur J Nucl Med Mol Imaging. 2015 Nov;42(12):1850-8. doi: 10.1007/s00259-015-3096-4. Epub 2015 Jun 11.
    pmid
    26062933
    type
    RESULT
  2. citation
    Iagaru A, Mosci C, Mittra E, Zaharchuk G, Fischbein N, Harsh G, Li G, Nagpal S, Recht L, Gambhir SS. Glioblastoma Multiforme Recurrence: An Exploratory Study of (18)F FPPRGD2 PET/CT. Radiology. 2015 Nov;277(2):497-506. doi: 10.1148/radiol.2015141550. Epub 2015 May 12.
    pmid
    25965900
    type
    RESULT
  3. citation
    Minamimoto R, Karam A, Jamali M, Barkhodari A, Gambhir SS, Dorigo O, Iagaru A. Pilot prospective evaluation of (18)F-FPPRGD2 PET/CT in patients with cervical and ovarian cancer. Eur J Nucl Med Mol Imaging. 2016 Jun;43(6):1047-55. doi: 10.1007/s00259-015-3263-7. Epub 2015 Nov 27.
    pmid
    26611425
    type
    RESULT
  4. citation
    Toriihara A, Duan H, Thompson HM, Park S, Hatami N, Baratto L, Fan AC, Iagaru A. 18F-FPPRGD2 PET/CT in patients with metastatic renal cell cancer. Eur J Nucl Med Mol Imaging. 2019 Jul;46(7):1518-1523. doi: 10.1007/s00259-019-04295-7. Epub 2019 Mar 8.
    pmid
    30850872
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice