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NCT05851365 · ClinicalTrials.gov registry record · Early Phase 1
Magnetic Resonance (MR) Imaging With Hyperpolarized Bicarbonate (13C) to Measure Tissue pH in Prostate Cancer
A Early Phase 1 study of Prostate Cancer and Localized Prostate Carcinoma, sponsored by Robert Flavell, MD, PhD.
- Active
- Registry status
- Early Phase 1
- Development phase
- 1
- Enrollment target
- 1
- Study location
NCT05851365: Active Early Phase 1 study of Prostate Cancer and Localized Prostate Carcinoma, sponsored by Robert Flavell, MD, PhD.
NCT05851365 is a Early Phase 1 study of Prostate Cancer and Localized Prostate Carcinoma that is active but no longer recruiting, run by Robert Flavell, MD, PhD. The registered enrollment target is 1 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05851365, a Early Phase 1 study of Prostate Cancer and Localized Prostate Carcinoma, is active but no longer recruiting, sponsored by Robert Flavell, MD, PhD.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 1 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single site, prospective pilot study to determine the feasibility and safety of the administration of HP 13C bicarbonate in 10 patients with prostate cancer to determine potential hydrogen (pH) values in surrounding tissue. The proposed study will evaluate pre-surgical participants with histologically confirmed localized prostate cancer who receive infusion of hyperpolarized 13C injection prior to MR imaging with endorectal coil.
Primary Outcome
The feasibility of a study will be determined by the ability to generate adequate signal to noise ratio to measure acidity (pH) in tumor or adjacent healthy tissue. This study will be considered successful if the 13C bicarbonate (CO2) and 13C-CO2 resonances in tumor or normal prostate are qualitatively detectable and signal to noise ratios are greater than 2. The point estimation and 95% confidence intervals (CI) of the participants having sufficient signal to noise ratio will be obtained using
Conditions Studied
Interventions
- DRUG Hyperpolarized Bicarbonate (13C)
- PROCEDURE Magnetic Resonance imaging
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2023-07-06 |
| Est. Completion | 2025-12-31 |
| Phase | Early Phase 1 |
What the registry record for NCT05851365 still lists
NCT05851365 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Hyperpolarized Bicarbonate (13C) is the first listed.
NCT05851365 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05851365 about?
NCT05851365 is a clinical study titled "Magnetic Resonance (MR) Imaging With Hyperpolarized Bicarbonate (13C) to Measure Tissue pH in Prostate Cancer". This is a single site, prospective pilot study to determine the feasibility and safety of the administration of HP 13C bicarbonate in 10 patients with prostate cancer to determine potential hydrogen (pH) values in surrounding tissue. The proposed study will evaluate pre-surgical participants with hi...
What is the current status of trial NCT05851365?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 1 participants. The study started on 2023-07-06. Estimated completion is 2025-12-31.
What conditions does trial NCT05851365 study?
This clinical trial studies the following conditions: Prostate Cancer, Localized Prostate Carcinoma.
What interventions are being tested in trial NCT05851365?
The interventions under investigation include: Hyperpolarized Bicarbonate (13C) (DRUG), Magnetic Resonance imaging (PROCEDURE).
Who is sponsoring clinical trial NCT05851365?
This trial is sponsored by Robert Flavell, MD, PhD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05851365 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05851365's enrollment target sits among peer trials
1 736th of 735 the lowest of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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