Clinical trial · Interventional
Choline PET/CT and MRI for Targeted Prostate Biopsy
Investigation of the Magnitude of Uptake, Retention, and Spatial Distribution Pattern of 18F-Choline in Comparison With MRI and Histology Obtained From Prostate Cancer Biopsies
NCT01751737CI-TRIAL-00040972completedN/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 research study will access the using of a radiotracer, 18F-choline PET/CT and MRI for prostate cancer in patients undergoing diagnostic prostate biopsy. Patients receive MRI guided prostate biopsies and metabolomic profiling of prostate biopsy tissues.
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 |
|---|---|---|---|
| Prostate Cancer Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prostate Cancer Imaging
- description
- Subjects will receive multi-sequence Magnetic Resonance Imaging (MRI) of the prostate and pelvis. This scan will take approximately 90 minutes. In addition, a 18F-Choline PET/CT(Positron emission tomography/computed tomography) scan of the abdomen and pelvis is performed. This scan will take about 30 minutes. Subjects may receive an additional 30 minute scan, if needed. Patients participating in an active surveillance program at the University of Michigan may receive yearly imaging followed by a prostate biopsy procedure.
- interventionNames
- Procedure: Prostate Cancer Imaging
Primary outcomes (1)
- measure
- Evaluation whether the odds of primary Gleason ≥ 3+4 are greater for image-guided biopsy (based on parametric PET/MRI) than for non-image-guided (standard) biopsy.
- timeFrame
- 4 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Males 40 years of age or older scheduled for prostate biopsy (for known or suspected prostate cancer) followed by planned prostatectomy (population group A) * Males 40 years of age or older with known (biopsy-confirmed) primary adenocarcinoma of the prostate undergoing active surveillance scheduled for prostate biopsy (population group B) Exclusion Criteria: * Androgen ablation (hormone treatment) within the last 3 months * Prostate biopsy within 6 weeks prior to PET or MRI imaging * Active inflammatory bowel disease within the last 6 months * Acute prostatitis within the last 6 months * A non-urologic bacterial infection requiring active treatment with antibiotics * Active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years * Previous radiation treatment of the pelvis * Symptomatic distal rectal stenosis * Known hypersensitivity to glucagon * Pheochromocytoma, insulinoma or galactosemia * Insulin-dependent diabetes
References
Publications (1)
- RESULTPiert M, Montgomery J, Kunju LP, Siddiqui J, Rogers V, Rajendiran T, Johnson TD, Shao X, Davenport MS. 18F-Choline PET/MRI: The Additional Value of PET for MRI-Guided Transrectal Prostate Biopsies. J Nucl Med. 2016 Jul;57(7):1065-70. doi: 10.2967/jnumed.115.170878. Epub 2016 Mar 16. PMID 26985061