Clinical trial · Interventional
Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2
NCT01383135CI-TRIAL-00072967completedEarly Phase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Non-Small-Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Other Cancers | Breast Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| F18-FPPRGD2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- OTHER
- label
- Healty Volunteers
- description
- Normal volunteers to receive 5 to 14 mCi F18-FPPRGD2 by intravenous (IV) injection.
- interventionNames
- Drug: F18-FPPRGD2
- type
- EXPERIMENTAL
- label
- Breast Cancer
- description
- Breast cancer patients to receive 4 to 11 mCi F18-FPPRGD2 by IV injection.
- interventionNames
- Drug: F18-FPPRGD2
- type
- EXPERIMENTAL
- label
- Glioblastoma Multiform (brain)
- description
- Glioblastoma multiform patients to receive 5 to14 mCi F18-FPPRGD2 by IV injection.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Healthy volunteers: 1. Must be 18 years of age or older. 2. Must have no known medical problems and have had a full medical exam within 6 months of the study. 3. Must understand and voluntarily have signed an Informed Consent after its contents have been fully explained. 4. Women of child bearing potential (as defined as women who are not post menopausal for 12 months or who have had no previous surgical sterilization). 5. Men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 30 days after the last dose. Cancer subjects: 1. Greater than 18 years-old at the time of radiotracer administration 2. Provides written informed consent 3. Diagnosed with advanced non-small cell lung cancer (NSCLC), breast cancer, pancreatic cancer and glioblastoma multiforme (GBM); patients will undergo bevacizumab or Cyberknife therapy 4. Able to remain still for duration of each imaging procedure (about one hour) Exclusion Criteria 1. Less than 18 years-old at the time of radiotracer administration 2. Pregnant or nursing
References
Publications (0)
Data not yet available
No reference posted for this study.