Clinical trial · Interventional
The Safety and Efficacy of 18F-Fluoromethylcholine (18F-FCH) PET/CT in Prostate Cancer
- 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 objectives of this study are to confirm the safety and efficacy of FCH-PET/CT and to establish our ability to reproduce results from the literature using FCH-PET/CT as a diagnostic and decision making tool in the management in two predefined groups of prostate cancer patients, specifically, biochemical recurrence and high risk staging. The primary endpoints of the study are the incidence of adverse events (AE) in the study population up to 24 hours following the scan, and the sensitivity and specificity of FCH-PET/CT vs CT on a per-patient and per-lesion basis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-Fluoromethylcholine (18F-FCH) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FCH-PET/CT
- description
- 18F-Fluoromethylcholine (18F-FCH) PET/CT
- interventionNames
- Drug: 18F-Fluoromethylcholine (18F-FCH)
Primary outcomes (3)
- measure
- Safety of FCH-PET/CT imaging as measured by the incidence of adverse events (AE)
- timeFrame
- 7 days
- measure
- Efficacy of FCH-PET/CT imaging as measured by sensitivity and specificity vs CT on a per patient basis as compared to standard of truth
- timeFrame
- 12 months
- measure
- Efficacy of FCH-PET/CT imaging as measured by sensitivity and specificity vs CT on a per lesion basis as compared to standard of truth
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Global Inclusion Criteria: * Resident of Canada * Male sex * Age 18 years or older * Previously diagnosed with prostate cancer, under referring physician's care * ECOG performance status 0 - 3, inclusive * Able to understand and provide written informed consent * Able to tolerate the physical/logistical requirements of completing a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation for injection Global Exclusion Criteria: * Patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive) * Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter) * Patients who are claustrophobic. Clinical Indication Criteria Subgroups: * BCR: Biochemical recurrence as defined by serum PSA \> 1 ng/ml following either radical prostatectomy or curative-intent radiotherapy or other prostate-ablative definitive management. * HRS: Staging of high risk patients as defined by any one of the following: * Gleason score \> 7 * Serum PSA \> 15 ng/ml * T stage of T3 or greater on TNM staging * Equivocal conventional staging such as CT, MRI or bone scan * Clinical suspicion of advance stage disease (e.g. bone pain)
References
Publications (0)
Data not yet available