Clinical trial · Interventional
18F-FCH (Fluorocholine)-PET/MR in Staging of High-Risk Prostate Cancer
18F-FCH-PET/MR in Staging of High-Risk Prostate Cancer: A Multiparametric Approach
NCT01993160CI-TRIAL-00025483completedN/AClinicalTrials.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)
This is a single centre, single arm feasibility study of 18FCH PET-MR imaging for staging patients with high risk prostate cancer. Study Hypothesis: FCH-PET/MR will enable more accurate staging of patients with high risk prostate cancer as compared to conventional imaging.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorocholine (18F-FCH) Injection | Drug | — | UNRESOLVED |
| PET scan | Radiation | — | UNRESOLVED |
| Whole body MRI | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 18F-FCH PET MR
- description
- Integrated whole body PET-MR or PET-CT and separate whole body MRI with use of 18F-FCH as the molecular probe
- interventionNames
- Drug: Fluorocholine (18F-FCH) Injection
- Radiation: PET scan
- Radiation: Whole body MRI
Primary outcomes (1)
- measure
- Number of prostate cancer foci detected with FCH PET/MR compared to MR alone.
- timeFrame
- 2 years
Secondary outcomes (1)
- measure
- Detection rate of lymph node and distant metastases in patients with high risk prostate cancer as compared to conventional imaging strategies (CT abdomen and bone scintigraphy).
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Histologic diagnosis of carcinoma of prostate * High risk disease: defined as Gleason ≥8, or T3 disease, or PSA \>20ng/mL * No prior therapy for prostate cancer (surgery, radiation therapy, hormone therapy, chemotherapy). * Ability to provide written informed consent to participate in the study Exclusion Criteria: * Prior surgery or radiation therapy for prostate cancer * Prior or ongoing hormone or other systemic therapy for prostate cancer * Inability to lie supine for 90 minutes * Any contraindication to MR as per Joint Department of Medical Imaging policies. * Impaired kidney function with glomerular filtration rate \< 30ml/min * Previous anaphylactic reaction to gadolinium or other contraindications to MR.
References
Publications (0)
Data not yet available
No reference posted for this study.