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

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ClinicalTrials.gov Identifier: NCT01806675
Recruitment Status : Completed
First Posted : March 7, 2013
Results First Posted : September 5, 2019
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sanjiv Sam Gambhir, Stanford University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Male Breast Cancer
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma
Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
Recurrent Adult Brain Tumor
Recurrent Basal Cell Carcinoma of the Lip
Recurrent Colon Cancer
Recurrent Esthesioneuroblastoma of the Paranasal Sinus and Nasal Cavity
Recurrent Hypopharyngeal Cancer
Recurrent Inverted Papilloma of the Paranasal Sinus and Nasal Cavity
Recurrent Laryngeal Cancer
Recurrent Lip and Oral Cavity Cancer
Recurrent Lymphoepithelioma of the Nasopharynx
Recurrent Lymphoepithelioma of the Oropharynx
Recurrent Metastatic Squamous Neck Cancer With Occult Primary
Recurrent Midline Lethal Granuloma of the Paranasal Sinus and Nasal Cavity
Recurrent Mucoepidermoid Carcinoma of the Oral Cavity
Recurrent Nasopharyngeal Cancer
Recurrent Non-small Cell Lung Cancer
Recurrent Oropharyngeal Cancer
Recurrent Pancreatic Cancer
Recurrent Paranasal Sinus and Nasal Cavity Cancer
Recurrent Rectal Cancer
Recurrent Renal Cell Cancer
Recurrent Salivary Gland Cancer
Stage IIIA Breast Cancer
Stage IIIA Non-small Cell Lung Cancer
Stage IIIB Breast Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Stage IV Non-small Cell Lung Cancer
Stage IV Pancreatic Cancer
Stage IV Renal Cell Cancer
Stage IVA Colon Cancer
Stage IVA Rectal Cancer
Stage IVA Salivary Gland Cancer
Stage IVB Colon Cancer
Stage IVB Salivary Gland Cancer
Stage IVC Salivary Gland Cancer
Tongue Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Interventions Drug: 18F-fludeoxyglucose (18F-FDG)
Drug: 18F-FPPRGD2
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Glioblastoma Multiforme (GBM) Gynecological Cancers Renal Cell Cancer (RCC)
Hide Arm/Group 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)

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.

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.

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.

Period Title: Overall Study
Started 11 6 8
Completed 11 6 8
Not Completed 0 0 0
Arm/Group Title Glioblastoma Multiforme (GBM) Gynecological Cancers Renal Cell Cancer (RCC) Total
Hide Arm/Group 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)

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 11 6 8 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 6 participants 8 participants 25 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
6
 100.0%
4
  50.0%
21
  84.0%
>=65 years
0
   0.0%
0
   0.0%
4
  50.0%
4
  16.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 6 participants 8 participants 25 participants
54.1  (8.3) 44.3  (12.6) 64.1  (13.3) 54.9  (13.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 6 participants 8 participants 25 participants
Female
5
  45.5%
6
 100.0%
3
  37.5%
14
  56.0%
Male
6
  54.5%
0
   0.0%
5
  62.5%
11
  44.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 6 participants 8 participants 25 participants
Hispanic or Latino
1
   9.1%
1
  16.7%
1
  12.5%
3
  12.0%
Not Hispanic or Latino
10
  90.9%
5
  83.3%
7
  87.5%
22
  88.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 6 participants 8 participants 25 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   9.1%
2
  33.3%
3
  37.5%
6
  24.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
8
  72.7%
2
  33.3%
4
  50.0%
14
  56.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
2
  18.2%
2
  33.3%
1
  12.5%
5
  20.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 6 participants 8 participants 25 participants
11 6 8 25
1.Primary Outcome
Title Change From Baseline in Maximum Standard Uptake Values (SUVmax)
Hide 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.
Time Frame At baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Some participants did not contribute some or all post-treatment scans.
Arm/Group Title Glioblastoma Multiforme (GBM) Gynecological Cancers Renal Cell Cancer (RCC)
Hide Arm/Group 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)

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.

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.

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 Number of Participants Analyzed 8 4 4
Median (Standard Deviation)
Unit of Measure: ratio
18F-FPPRGD2 PET scans Number Analyzed 8 participants 4 participants 3 participants
-0.98  (0.98) 0.09  (1.20) 0.10  (0.29)
18F-FDG PET scans Number Analyzed 0 participants 4 participants 3 participants
-1.90  (2.80) 7.8  (8.2)
2.Secondary Outcome
Title Response Assessment by RANO Criteria
Hide 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

Time Frame At baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
This assessment was restricted to glioblastoma multiforme (GBM) participants only, however, no response assessments were obtained for GBM participants.
Arm/Group Title Glioblastoma Multiforme (GBM) Gynecological Cancers Renal Cell Cancer (RCC)
Hide Arm/Group 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)

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.

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.

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 Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change in Tumor Size
Hide 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.
Time Frame 9 to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Glioblastoma Multiforme (GBM) Gynecological Cancers Renal Cell Cancer (RCC)
Hide Arm/Group 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)

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.

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.

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 Number of Participants Analyzed 0 3 3
Median (Standard Deviation)
Unit of Measure: centimeters
0.9  (1.56) 1  (1.56)
4.Secondary Outcome
Title Tumor Response Rate by EORTC Criteria
Hide 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
Time Frame At baseline and 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Glioblastoma Multiforme (GBM) Gynecological Cancers Renal Cell Cancer (RCC)
Hide Arm/Group 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)

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.

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.

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 Number of Participants Analyzed 0 4 4
Measure Type: Number
Unit of Measure: participants
Complete Response (CR) 2 0
Partial Repsonse (PR) 1 0
Stable Disease (SD) 0 2
Progressive Disease 1 2
5.Secondary Outcome
Title Progression-free Survival (PFS)
Hide 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.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for progression-free survival (PFS).
Arm/Group Title Glioblastoma Multiforme (GBM) Gynecological Cancers Renal Cell Cancer (RCC)
Hide Arm/Group 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)

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.

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.

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 Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Glioblastoma Multiforme (GBM) Gynecological Cancers Renal Cell Cancer (RCC)
Hide Arm/Group 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)

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.

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.

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.

All-Cause Mortality
Glioblastoma Multiforme (GBM) Gynecological Cancers Renal Cell Cancer (RCC)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/11 (9.09%)      0/6 (0.00%)      0/8 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Glioblastoma Multiforme (GBM) Gynecological Cancers Renal Cell Cancer (RCC)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/11 (9.09%)      0/6 (0.00%)      2/8 (25.00%)    
Gastrointestinal disorders       
Diarrhea  2  0/11 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  1
Vomiting  1  0/11 (0.00%)  0 0/6 (0.00%)  0 1/8 (12.50%)  2
General disorders       
Death NOS  1  1/11 (9.09%)  1 0/6 (0.00%)  0 0/8 (0.00%)  0
1
Term from vocabulary, CTCAE v (4.0)
2
Term from vocabulary, CTCAE v4.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Glioblastoma Multiforme (GBM) Gynecological Cancers Renal Cell Cancer (RCC)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/11 (0.00%)      0/6 (0.00%)      0/8 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sanjiv Sam Gambhir, Professor for Clinical Investigation in Cancer Research and Professor
Organization: Stanford University
Phone: 650-725-6175
EMail: sgambhir@stanford.edu
Layout table for additonal information
Responsible Party: Sanjiv Sam Gambhir, Stanford University
ClinicalTrials.gov Identifier: NCT01806675     History of Changes
Other Study ID Numbers: IRB-25970
NCI-2013-00535 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
IRB-25970 ( Other Identifier: Stanford IRB )
VARIMG0002 ( Other Identifier: OnCore ID )
First Submitted: March 5, 2013
First Posted: March 7, 2013
Results First Submitted: August 14, 2019
Results First Posted: September 5, 2019
Last Update Posted: October 3, 2019