Clinical trialEPhase 1Completed
Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2
- Outcome
- Outcome unknown
- Phase
- EPhase 1
- Status
- Completed
- Study type
- Interventional
- Start
- October 2010
- Expected end
- December 2013
- Enrollment
- 27 participants
- Sites
- 1
- Primary outcomes
- Tracer Dosimetry by Organ; F18-FPPRGD2 Time-activity at Specified Timepoints; Sensitivity of F18-FPPRGD2 PET/CT in Breast Cancer; Specificity of F18 FPPRGD2 PET/CT in Breast Cancer; Glioblastoma Primary Tumor Response Assessed by PET Scan
- Sponsor
- Other
- Results posted
- 2024-01-12
- Last update
- 12 January 2024
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Brief summary public domain (ClinicalTrials.gov)
The purpose of the study was to conduct a pilot test of new tracers (\[18F\]FPRGD2 and \[18F\]FPPRGD2) to define normal tracer biodistribution (where the tracer goes), stability (how much metabolises), pharmacokinetics (how much stays in which organs and for how long), and radiation dosimetry (organ radiation dose). Healthy volunteers provided the normal biodistribution data. The same radiopharmaceutical was also tested in breast cancer, glioblastoma multiform (brain cancer), and lung cancer.
Detailed description public domain (ClinicalTrials.gov)
The tracer \[18F\]FPRGD2 was not evaluated in this study. The protocol title was never amended to reflect this.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Tracer Dosimetry by Organ [5 hours]. Mean, mSv/MBq (Standard Deviation). Kidneys: Healthy Volunteers (n=4): 0.3603 (0.1852). Liver: Healthy Volunteers (n=4): 0.0988 (0.0379). Bladder: Healthy Volunteers (n=4): 0.8615 (0.4362). Bowel: Healthy Volunteers (n=4): 0.5290 (0.2364).
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
F18-FPPRGD2 Time-activity at Specified Timepoints [30, 60, and 90 minutes post-injection]. Mean, Percentage of tracer remaining in blood (Standard Deviation). 30 minutes post-injection: Healthy Volunteers (n=4): 26 (17). 60 minutes post-injection: Healthy Volunteers (n=4): 18 (14). 90 minutes post-injection: Healthy Volunteers (n=4): 8 (2).
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Sensitivity of F18-FPPRGD2 PET/CT in Breast Cancer [3 hours]. Number, percentage of sensitivity. Breast Cancer Patients (n=8): 95.7.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Specificity of F18 FPPRGD2 PET/CT in Breast Cancer [an estimated average of 3 hours]. Number, percentage of specificity. Breast Cancer Patients (n=8): 100.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Glioblastoma Primary Tumor Response Assessed by PET Scan [Baseline and Week 6]. Mean, SUVmax (Standard Deviation). Pretreatment: Glioblastoma Multiforme (n=6): 1.7 (0.6). Week 6: Glioblastoma Multiforme (n=6): 1.3 (0.5). Analysis, Glioblastoma Multiforme: p=.034; t-test, 2 sided; superiority or other legacy.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Glioblastoma Primary Tumor Response Assessed by CT Scan [Baseline and Week 6]. Mean, percentage change (Standard Deviation). Glioblastoma Multiforme (n=6): -11.0 (80.7).