Hyperpolarized 13C MRI as a Biomarker in Advanced Solid Tumors

Part of paid clinical trials in San Francisco, California.

Sponsor
Robert Bok, MD, PhD
Study ID
NCT05599048
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hyperpolarized 13C-Pyruvate — DRUG
    Given IV
  • Magnetic Resonance Imaging (MRI) — PROCEDURE
    Imaging procedure
  • 13C,15N-Urea — DRUG
    Given IV

Study Details

This is a single center prospective imaging study investigating the utility of hyperpolarized 13C-pyruvate +/-13C,15N-Urea/ metabolic MR imaging. The current protocol will serve as a companion imaging biomarker study paired with standard of care (SOC) therapeutics, as well as investigational therapies that participants may be scheduled to receive outside of this protocol.

Key Dates

Start date
Dec 15, 2022
Status verified
Mar 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
65 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A / Phase 1: Feasibility Run-In
    Participants will undergo MR imaging at a single time point. Imaging will take one day and no follow up is planned.
  • Experimental: Part B/ Phase II: Biomarker Cohort
    Participants will undergo paired 13C-pyruvate +/- 13C,15N-urea/metabolic MR imaging at baseline and again after approximately 21 days of therapy. Duration of the intervention period is approximately 21 days, and participants will be followed until discontinuation of their current SOC treatment regimen, about 6 months.

Primary Outcome Measure

Signal-to-noise ratio (Part A) [ Time Frame: Day of imaging (1 day) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Louise Magat
[email protected]
415-502-1822
[email protected]
877-827-3222
Robert Bok, MD, PhD (PRINCIPAL_INVESTIGATOR)

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