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NCT Number: NCT05697406

HP Pyruvate MRI in Cancers

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.

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Key information

Conditions

Image Neoplasms Tumors Warburg Effect

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location status: Recruiting

Location contact

Rosy Njonkou, MA

CONTACT

[email protected]

410-706-0943

About this study

Most cancers exhibit the Warburg effect, which involves synthesis of lactate via glycolytic pathways. The present method of using 18F-FDG to image metabolic events only evaluates early glycolysis and does not investigate late glycolytic effects which can be examined by 13C pyruvate. The ability to detect cancer using 13C pyruvate has been shown using ovarian cancer models and in the prostate in humans, however its utility in other tumors needs clarification. Because cancers of various types affect metabolic pathways, it is necessary to improve imaging techniques to better investigate downstream metabolism. Many studies have shown that there are higher lactate levels in cancer tissue and higher levels of glycolysis. 13C pyruvate imaging takes advantage of these pathways by imaging the tumors while undergoing pyruvate to lactate conversion . From this modality, a three dimensional visualization of the tumor and metabolic products created by the pyruvate can be investigated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical tumor diagnosis

Patients with pre-existing MR imaging appointments

Must be able to undergo MR

Exclusion criteria

No tumor diagnosis

Treatment and study plan

Hyperpolarized 13C-Pyruvate

Drug

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

Primary outcomes

  1. Pyruvate to Lactate Conversion

    Time frame: 18-36 months

    Imaging Quality, KpL

Secondary outcomes

  1. SNR

    Time frame: 12-42 months

    Signal to Noise Ratio, dB

  2. CNR

    Time frame: 12-42 months

    Contrast to Noise

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

Hyperpolarized 13-C Pyruvate MRI Surveillance of Multiple Cancers

Acronym: HC-MRI

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jan 25, 2023
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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