Clinical trial · Interventional
11C- and 18F-Choline PET/MR Imaging for Prostate Cancer
Phase 2 Study of 11C- and 18F-Choline PET/MR Imaging in Patients With Unfavorable Intermediate to High-Risk 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)
This phase II trial studies how well 11C-choline (carbon C 11 choline) and 18F-choline (fluorine F 18 choline) positron emission tomography/magnetic resonance (PET/MR) imaging works in diagnosing patients with unfavorable intermediate to high-risk prostate cancer. Diagnostic procedures, such as 11C- and 18F-choline PET/MR may help find and diagnose prostate cancer and find out how far the disease has spread.
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 |
|---|---|---|---|
| Carbon C 11 Choline | Drug | — | UNRESOLVED |
| Fluorine F 18 Choline | Drug | — | UNRESOLVED |
| Positron Emission Tomography (PET) / Magnetic Resonance Imaging (MRI) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic 11C- and 18F-choline PET/MR imaging
- description
- Patients are given 370 megabecquerel (MBq) 11C-Choline (11C) intravenously and 3 MBq/kg 18F-Choline (18F) intravenously prior to a whole-body PET/MR imaging
- interventionNames
- Drug: Carbon C 11 Choline
- Drug: Fluorine F 18 Choline
- Procedure: Positron Emission Tomography (PET) / Magnetic Resonance Imaging (MRI)
Primary outcomes (11)
- measure
- Mean Kinetic Parameters Reflecting Fluorocholine (FCH) Fluorine 18 FCH (F-18) Influx (K1)
- timeFrame
- Day 1
- description
- The average K1 values of primary tumors will be reported along with the standard deviation
- measure
- Mean Maximum Kinetic Parameters Reflecting F-18 Influx (K1max)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age: Patients must be \>=18 years of age * Diagnosis: Patients must have a diagnosis of prostate cancer by histologic verification and a hypoechoic lesion seen on ultrasound. * Disease Status: Unfavorable intermediate to high-risk prostate cancer, per the Cancer of the Prostate Risk Assessment Score (CAPRA) (CAPRA 5-10) * Karnofsky Performance Status \>=70 * Metastatic workup: Whole Body Sodium Fluoride (NaF) PET/CT or 99mTc Bone Scan * Planned to undergo radical prostatectomy and extended pelvic lymph node dissection * Adequate bone marrow and organ function defined as follows: * Adequate bone marrow function: * Leukocytes \>= 3,000/microliter (mcL) * Absolute Neutrophil Count \>= 1,500/mcL * Platelets \>= 100,000/mcL * Adequate hepatic function: * Total bilirubin - within normal institutional limits * Aspartate aminotransferase (AST)/ serum glutamic-oxaloacetic transaminase (SGOT) \<= 2.5 X institutional upper limit of normal * Alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) \<= 2.5 X institutional upper limit of normal * Adequate renal function: * Creatinine - within normal institutional limits OR * Creatinine clearance \>= 60 mL/min/ 1.73m2 for patients with creatinine levels above institutional normal * Ability to understand a written informed consent document, and the willingness to sign it Exclusion Criteria: * Participation would significantly delay the scheduled standard of care therapy * Karnofsky performance status of \< 60 * Inadequate venous access * Administered a radioisotope within 5 physical half lives prior to study enrollment * Have a medical condition or other circumstances which, in the opinion of the investigator would significantly decrease the chances of obtaining reliable data, achieving the study objectives, or completing the study.
References
Publications (1)
- RESULTChoi JY, Yang J, Noworolski SM, Behr S, Chang AJ, Simko JP, Nguyen HG, Carroll PR, Kurhanewicz J, Seo Y. 18F Fluorocholine Dynamic Time-of-Flight PET/MR Imaging in Patients with Newly Diagnosed Intermediate- to High-Risk Prostate Cancer: Initial Clinical-Pathologic Comparisons. Radiology. 2017 Feb;282(2):429-436. doi: 10.1148/radiol.2016160220. Epub 2016 Aug 11. PMID 27513849