Trial Outcomes & Findings for 18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy (NCT NCT01806675)
NCT ID: NCT01806675
Last Updated: 2019-10-03
Results Overview
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.
COMPLETED
PHASE1/PHASE2
25 participants
At baseline and 6 weeks
2019-10-03
Participant Flow
Participant milestones
| Measure |
Glioblastoma Multiforme (GBM)
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.
|
Gynecological Cancers
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.
|
Renal Cell Cancer (RCC)
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
6
|
8
|
|
Overall Study
COMPLETED
|
11
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy
Baseline characteristics by cohort
| Measure |
Glioblastoma Multiforme (GBM)
n=11 Participants
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.
|
Gynecological Cancers
n=6 Participants
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.
|
Renal Cell Cancer (RCC)
n=8 Participants
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.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
44.3 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
64.1 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
54.9 years
STANDARD_DEVIATION 13.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
25 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At baseline and 6 weeksPopulation: Some participants did not contribute some or all post-treatment scans.
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.
Outcome measures
| Measure |
Glioblastoma Multiforme (GBM)
n=8 Participants
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.
|
Gynecological Cancers
n=4 Participants
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.
|
Renal Cell Cancer (RCC)
n=4 Participants
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.
|
|---|---|---|---|
|
Change From Baseline in Maximum Standard Uptake Values (SUVmax)
18F-FPPRGD2 PET scans
|
-0.98 ratio
Standard Deviation 0.98
|
0.09 ratio
Standard Deviation 1.20
|
0.10 ratio
Standard Deviation 0.29
|
|
Change From Baseline in Maximum Standard Uptake Values (SUVmax)
18F-FDG PET scans
|
—
|
-1.90 ratio
Standard Deviation 2.80
|
7.8 ratio
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: At baseline and 6 weeksPopulation: This assessment was restricted to glioblastoma multiforme (GBM) participants only, however, no response assessments were obtained for GBM participants.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 9 to 12 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Glioblastoma Multiforme (GBM)
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.
|
Gynecological Cancers
n=3 Participants
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.
|
Renal Cell Cancer (RCC)
n=3 Participants
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.
|
|---|---|---|---|
|
Change in Tumor Size
|
—
|
0.9 centimeters
Standard Deviation 1.56
|
1 centimeters
Standard Deviation 1.56
|
SECONDARY outcome
Timeframe: At baseline and 6 weeksPopulation: 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.
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
Outcome measures
| Measure |
Glioblastoma Multiforme (GBM)
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.
|
Gynecological Cancers
n=4 Participants
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.
|
Renal Cell Cancer (RCC)
n=4 Participants
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.
|
|---|---|---|---|
|
Tumor Response Rate by EORTC Criteria
Complete Response (CR)
|
—
|
2 participants
|
0 participants
|
|
Tumor Response Rate by EORTC Criteria
Partial Repsonse (PR)
|
—
|
1 participants
|
0 participants
|
|
Tumor Response Rate by EORTC Criteria
Stable Disease (SD)
|
—
|
0 participants
|
2 participants
|
|
Tumor Response Rate by EORTC Criteria
Progressive Disease
|
—
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Data was not collected for progression-free survival (PFS).
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.
Outcome measures
Outcome data not reported
Adverse Events
Glioblastoma Multiforme (GBM)
Gynecological Cancers
Renal Cell Cancer (RCC)
Serious adverse events
| Measure |
Glioblastoma Multiforme (GBM)
n=11 participants at risk
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.
|
Gynecological Cancers
n=6 participants at risk
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.
|
Renal Cell Cancer (RCC)
n=8 participants at risk
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.
|
|---|---|---|---|
|
General disorders
Death NOS
|
9.1%
1/11 • Number of events 1 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
0.00%
0/8 • 6 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/11 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
12.5%
1/8 • Number of events 1 • 6 weeks
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • 6 weeks
|
0.00%
0/6 • 6 weeks
|
12.5%
1/8 • Number of events 2 • 6 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Sanjiv Sam Gambhir, Professor for Clinical Investigation in Cancer Research and Professor
Stanford University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place