Clinical trial · Observational
Development and Evaluation of a Quantitative HP MRI for Clinical Prostate Cancer Exam
Development &Amp; Evaluation of a Quantitative HP MRI Clinical Prostate Cancer Exam
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Why stopped (as posted): No Participants Enrolled
Summary
Brief summary (as posted)
This trial examines if a prostate magnetic resonance spectroscopic imaging can be performed on a 3T scanner using an investigational contrast called hyperpolarized 13-C pyruvate for the development of a clinical prostate cancer exam. 3T refers to the strength of the magnetic resonance spectroscopic imaging (MRSI) machine. MRSI is a magnetic resonance imaging (MRI) technique that can show certain chemical differences in healthy and diseased prostate tumor tissue compared to standard multiparametric MRI that may not detect the tumor. Hyperpolarized (HP) 13-C pyruvate is a contrast drug that may help the scanner see the tumor site better during imaging. Hyperpolarization of 13-C pyruvate may allow pyruvate and its metabolites to be detected upon injection, which in turn, allow the prostate cancer to be found and treated.
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 Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperpolarized Carbon C 13 Pyruvate | Other | — | UNRESOLVED |
| Magnetic Resonance Spectroscopic Imaging | Procedure | — | UNRESOLVED |
| Surgical Procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Arm Ia (MRSI)
- description
- Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy.
- interventionNames
- Other: Hyperpolarized Carbon C 13 Pyruvate
- Procedure: Magnetic Resonance Spectroscopic Imaging
- label
- Arm Ib (MRSI)
- description
- Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy and at a second time 3-4 weeks after.
- interventionNames
- Other: Hyperpolarized Carbon C 13 Pyruvate
- Procedure: Magnetic Resonance Spectroscopic Imaging
- label
- Arm II (MRSI, surgery)
- description
- Patients receive hyperpolarized carbon C 13 pyruvate IV and undergo MRSI at least 5 weeks after prostate cancer biopsy, followed by standard of care surgery within 6 months after.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven prostate adenocarcinoma (Arm 1 \& 2) * Clinically appropriate for active surveillance (Arm 1) * Prior prostate biopsy must have been performed at least 5 weeks prior imaging (Arm 1 \& 2) * Patient must be scheduled to undergo radical prostatectomy within 6 months of multi-parametric magnetic resonance imaging (MP-MRI) + hyperpolarized (HP) \[1-13C\]-pyruvate imaging, consistent with American College of Radiology Imaging Network (ACRIN) Protocol: ACRIN 6659 (Arm 2) * At least 10% of enrolled patients will have high risk of disease progression (Cancer of the Prostate Risk Assessment - \[CAPRA\] 6-10) and no more than 50% of enrolled patients will have low risk of progression (CAPRA \< 3) (Arm 2) Exclusion Criteria: * Contraindication to MRI (Arm 1 \& 2) * Allergy to gadavist intravenous contrast (Arm 1 \& 2) * Any known medical history of arrhythmias such as atrial fib, etc. (Arm 1 \& 2) * Prior therapy for prostate cancer, except for 5-alpha reductase inhibitor discontinued at least one month prior to imaging (Arm 1 \& 2)
References
Publications (0)
Data not yet available