Spots Global Cancer Trial Database for Hyperpolarized 13C Pyruvate as a Biomarker in Advanced Solid Tumors

Study Description

Brief 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.

Detailed 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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