Clinical trial · Interventional
Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging
Utility of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging in the Diagnosis and Risk-Stratification of Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): "Study terminated due to institutional resource constraints, including limited availability of specialized equipment and technical support. Termination was not related to participant safety, data quality, study conduct, or the investigational product
Summary
Brief summary (as posted)
This is a two-tiered pilot study in which there will be no randomization and no placebo treatment. This study will be to perform metabolic magnetic resonance imaging on men suspected to have a prostate cancer to understand if metabolic MRI can be safely performed on this population
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 |
|---|---|---|---|
| Hyperpolarized 13C-Pyruvate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single-arm study in patients who are suspected or known to have prostate cancer
- description
- Perform metabolic magnetic resonance imaging on men suspected to have a prostate cancer to understand if metabolic MRI can be safely performed on this population
- interventionNames
- Drug: Hyperpolarized 13C-Pyruvate
Primary outcomes (1)
- measure
- CTCAE v4.0 Higher Than Grade 2
- timeFrame
- Within three years post treatment
- description
- Quantify the number of participants who get this scan and have treatment-related adverse events as assessed by CTCAE v4.0 higher than grade 2. Determine the number of participants who successfully complete a scan which meets a minimum quality standard as measured by signal to noise ratio on the scan, hyperpolarized metabolic MRI in the diagnosis of prostate cancer.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age greater than 40 and less than 80 years 2. Clinical suspicion or history of prostate cancer reflected by one of the following: * PSA \> 4ng/ml * Abnormal DRE exam * Known tissue diagnosis of prostate cancer from prior workup 3. Patient planning to undergo either a MRI targeted biopsy or radical prostatectomy for prostate cancer workup or treatment Exclusion Criteria: 1. Inability to undergo MRI scan 2. Inability to receive IV contrast as per institutional protocol.
References
Publications (0)
Data not yet available