Magnetic Resonance (MR) Imaging With Hyperpolarized Bicarbonate (13C) to Measure Tissue pH in Prostate Cancer

StatusRecruiting
PhaseEarly Phase 1
Started

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Record History

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  1. Enrollment reopened Show 6 more changesShow less
    • Enrollment increased: 1 → 10 participants
    • Primary endpoints: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description revised
    • Site details revised
  2. Primary and study completion dates: Dec 31, 2025 to Dec 31, 2027v5
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 10 to confirmed 1
    • Site details revised
    v4
  4. Study description expanded, about 34 words
    • Collaborators: 1 to 2
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 1, 2023 to Jul 6, 2023
    • Site details revised
    v2
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05851365
Lead Sponsor Robert Flavell, MD, PhD
Collaborators: U.S. Army Medical Research Acquisition Activity, Bristol-Myers Squibb
Conditions
(from sponsor)		 Prostate Cancer, Localized Prostate Carcinoma
Related terms Prostatic Neoplasms
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov