This phase I/II trial studies whether hyperpolarized carbon (C)-13 pyruvate with or without urea magnetic resonance imaging (MRI) is useful for monitoring tumor response to treatment in patients with advanced solid tumors. Hyperpolarized C-13 pyruvate is different from standard clinical MRI contrast (gadolinium) in that it provides information on how a tumor processes nutrients. The MRI scan can see how the tumor takes in and breaks down hyperpolarized carbon-13 pyruvate molecules, and how the tumor is processing nutrients. This can be helpful in understanding how tumors are responding to treatments.
Additional locations may be listed on ClinicalTrials.gov for NCT05599048.
Locations matching your search criteria
United States
California
San Francisco
University of California San FranciscoStatus: Active
Contact: Robert A. Bok
Phone: 415-514-4873
PRIMARY OBJECTIVES:
I. To optimize the signal-to-noise ratio in detecting intra-tumoral hyperpolarized 13C-pyruvate/lactate signal and hyperpolarized urea area under the curve (AUC) using metabolic MR imaging in patients with advanced solid tumors. (Phase I/Part A)
II. To determine the mean percent change from baseline in peak intra-tumoral hyperpolarized lactate-to-pyruvate ratio and pyruvate-to-lactate kinetic constant (kPL) and urea AUC after initiation of standard of care (SOC) or investigational treatment. (Phase II/Part B)
SECONDARY OBJECTIVES:
I. To further characterize the safety profile of hyperpolarized 13C-pyruvate, hyperpolarized carbon C 13/nitrogen N 15-labeled urea (15N-urea). (Phase I/Part A)
II. To determine the reproducibility of intra-tumoral hyperpolarized (HP) Lactate/pyruvate (lac/pyr) ratio and/or HP urea AUC with same-day repeated dose studies. (Phase I/Part A)
III. To study the association between clinical outcomes and the percent change from baseline in peak intra-tumoral hyperpolarized lactate-to-pyruvate ratio and kPL (+/- correction for HP urea AUC) after initiation of SOC treatment. (Phase II/Part B)
IV. To further characterize the safety profile of hyperpolarized 13C-pyruvate +/- 13C, 15N-urea. (Phase II/Part B)
V. To determine the reproducibility of intra-tumoral HP lac/pyr ratio and/or HP urea AUC with same-day repeated dose studies. (Phase II/Part B)
EXPLORATORY (CORRELATIVE) OBJECTIVES:
I. To investigate for an association between intra-tumoral hyperpolarized lactate to pyruvate ratio with histologic markers of proliferation and glycolytic metabolism, including Ki-67 and LDH expression, and hyperpolarized urea AUC with histological assessment of vascularity. (Part B)
II. To determine intra-tumoral peak HP lactate/pyruvate ratio and urea AUC. (Part A and B)
OUTLINE:
Patients receive hyperpolarized 13C-pyruvate intravenously with or without 13C,15N-urea intravenously (IV) and undergo MRI scan on study. Patients also undergo collection of blood samples at screening.
Lead OrganizationUniversity of California San Francisco
Principal InvestigatorRobert A. Bok
