Hyperpolarized 13C Pyruvate as a Biomarker in Advanced Solid Tumors

Status Recruiting

Clinical Trial Summary

This is a single center prospective imaging study investigating the utility of hyperpolarized 13C-pyruvate/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.

Clinical Trial Description

PRIMARY OBJECTIVES: Phase I/Part A 1. To optimize the signal-to-noise ratio in detecting intra-tumoral hyperpolarized 13C pyruvate/lactate signal using metabolic MR imaging in participants with advanced solid tumors. Phase II/Part B 1. To determine the mean percent change from baseline in peak intra-tumoral hyperpolarized lactate-to-pyruvate ratio and pyruvate-to-lactate kinetic constant (kPL) after initiation of SOC treatment. SECONDARY OBJECTIVES: Phase I/Part A 1. To further characterize the safety profile of hyperpolarized 13C-pyruvate. 2. To determine the reproducibility of intra-tumoral HP lac/pyr ratio with same-day repeated dose studies. Phase II/Part B 1. To study the association between clinical outcomes and the percent change from baseline in peak intra-tumoral hyperpolarized lactate-to-pyruvate ratio and kPL after initiation of SOC treatment. 2. To further characterize the safety profile of hyperpolarized 13C pyruvate. 3. To determine the reproducibility of intra-tumoral HP lac/pyr ratio with same-day repeated dose studies. OUTLINE: Participants will be enrolled in Part A which is the feasibility, run-in study which includes the iterative adjustment of coil design to optimize imaging parameters within the target tumor lesion(s). If the data from Part A supports further investigation, additional participants will be enrolled in Part B which is a biomarker cohort which includes participants who are planning on being treated with either standard-of-care (SOC) or investigational therapies and will be followed until discontinuation of the treatment regimen outside of this protocol. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05599048
Study type	Interventional
Source	University of California, San Francisco
Contact	Louise Magat
Phone	(415) 502-1822
Email	Louise.Magat@ucsf.edu
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	December 15, 2022
Completion date	January 31, 2026

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.