Phase 2
Completed N=25
18F-FPPRGD2 PET/CT or PET/MRI in Predicting Early Response in Patients With Cancer Receiving Anti-Angiogenesis Therapy
Adult Giant Cell Glioblastoma · Adult Glioblastoma · Adult Gliosarcoma · male breast cancer
Source: ClinicalTrials.gov NCT01806675 ↗
Enrolled (actual)
25
Serious AEs
12.0%
Results posted
Sep 2019
Primary outcomePrimary: Change From Baseline in Maximum Standard Uptake Values (SUVmax) — -0.98; 0.09; 0.10; -1.90 ratio
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Maximum Standard Uptake Values (SUVmax) |
-0.98; 0.09; 0.10; -1.90; 7.8 | — |
| SECONDARY Response Assessment by RANO Criteria |
— | — |
| SECONDARY Change in Tumor Size |
0.9; 1 | — |
| SECONDARY Tumor Response Rate by EORTC Criteria |
2; 0; 1; 0; 0; 2 | — |
| SECONDARY Progression-free Survival (PFS) |
— | — |
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)
Data sourced from ClinicalTrials.gov (NCT01806675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.