Clinical trialPhase 1 / Phase 2Completed
18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy
Phase 1-2 18F-FPPRGD2 PET/CT or PET/MRI Imaging of αvβ3 Integrins Expression as a Biomarker of Angiogenesis
- Outcome
- Outcome unknown
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 4 March 2013
- Expected end
- April 2019
- Enrollment
- 25 participants
- Sites
- 1
- Primary outcomes
- Change From Baseline in Maximum Standard Uptake Values (SUVmax)
- Sponsor
- Other
- Results posted
- 2019-09-06
- Last update
- 3 October 2019
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Change From Baseline in Maximum Standard Uptake Values (SUVmax) [At baseline and 6 weeks]. Median, ratio (Standard Deviation). 18F-FPPRGD2 PET scans: Glioblastoma Multiforme (GBM) (n=8): -0.98 (0.98); Gynecological Cancers (n=4): 0.09 (1.20); Renal Cell Cancer (RCC) (n=4): 0.10 (0.29). 18F-FDG PET scans: Gynecological Cancers (n=4): -1.90 (2.80); Renal Cell Cancer (RCC) (n=4): 7.8 (8.2).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Response Assessment by RANO Criteria [At baseline and 6 weeks].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Change in Tumor Size [9 to 12 weeks]. Median, centimeters (Standard Deviation). Gynecological Cancers (n=3): 0.9 (1.56); Renal Cell Cancer (RCC) (n=3): 1 (1.56).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Tumor Response Rate by EORTC Criteria [At baseline and 6 weeks]. Number, participants. Complete Response (CR): Gynecological Cancers (n=4): 2; Renal Cell Cancer (RCC) (n=4): 0. Partial Repsonse (PR): Gynecological Cancers (n=4): 1; Renal Cell Cancer (RCC) (n=4): 0. Stable Disease (SD): Gynecological Cancers (n=4): 0; Renal Cell Cancer (RCC) (n=4): 2. Progressive Disease: Gynecological Cancers (n=4): 1; Renal Cell Cancer (RCC) (n=4): 2.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-free Survival (PFS) [1 year].
Papers 4
- Registry-listed results paper18F-FPPRGD2 PET/CT in patients with metastatic renal cell cancer. DOI 10.1007/s00259-019-04295-7↗
- Registry-listed results paperPilot prospective evaluation of (18)F-FPPRGD2 PET/CT in patients with cervical and ovarian cancer. DOI 10.1007/s00259-015-3263-7↗
- Registry-listed results paperBiodistribution of the ¹⁸F-FPPRGD₂ PET radiopharmaceutical in cancer patients: an atlas of SUV measurements. DOI 10.1007/s00259-015-3096-4↗
- Registry-listed results paperGlioblastoma Multiforme Recurrence: An Exploratory Study of (18)F FPPRGD2 PET/CT. DOI 10.1148/radiol.2015141550↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.