Recruiting
Phase 1
Phase 2

HP Pyruvate

Sponsor:

University of Maryland, Baltimore

Code:

NCT05697406

Conditions

Image

Warburg Effect

Tumors

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Hyperpolarized 13C-Pyruvate

Study Details

Brief summary:

Many human diseases are characterized by their ability to alter existing metabolic pathways and interrupt cellular processes. Cancer exploits the Warburg effect and utilizes greater glucose than normal cells and within this process uses anaerobic respiration, leading to increased conversion of pyruvate to lactate. This can be exploited by hyperpolarized imaging. Hyperpolarized 13C MRI imaging is an approach that utilizes a stable isotope of Carbon (13C) linked to pyruvate. MRI spectroscopy is used in conjunction with hyperpolarized 13C pyruvate in order to temporally detect pyruvate and its conversion to lactate in-vivo, in order to visualize downstream metabolic (glycolytic) activity secondary to the Warburg effect, which should be useful in detecting and characterizing tumors of various types. Hyperpolarized 13C pyruvate MR imaging has not been tested in most cancers. In this preliminary survey, we will test the hypothesis that hyperpolarized 13C pyruvate MR imaging can be used to image various cancers.

Conditions

Image

Warburg Effect

Tumors

Study ID

NCT05697406

Start date

Jun 24, 2024

Status verified date

Sep, 2025

Completion date

Dec 1, 2028

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Clinical tumor diagnosis

Patients with pre-existing MR imaging appointments

Must be able to undergo MR

Exclusion Criteria:

No tumor diagnosis

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Experimental

Participants will receive an injection of 250 mM of hyperpolarized 13-C pyruvate intravenously after standard of care imaging sequences are performed. Then participants will undergo HP-MR imaging.

Interventions

Hyperpolarized 13C-Pyruvate

Imaging tumors pre and post administration of hyperpolarized 13-C pyruvate injection.

Primary outcome measure

  • Pyruvate to Lactate Conversion [ Time Frame: 18-36 months ]

Central Contacts and Locations

Locations

University of Maryland Medical Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Sep 22, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2025-09-22.