HP Pyruvate MRI in Cancers

NCT05697406 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: HP-00101177
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pyruvate to Lactate Conversion

  Imaging Quality, KpL

  18-36 months

Secondary Outcomes (2)

• SNR

  12-42 months

• CNR

  12-42 months

Study Arms (1)

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.

Drug: Hyperpolarized 13C-Pyruvate

Interventions

Hyperpolarized 13C-Pyruvate DRUG

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

Experimental

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical tumor diagnosis
• Patients with pre-existing MR imaging appointments
• Must be able to undergo MR

You may not qualify if:

• No tumor diagnosis

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

Related Publications (3)

• Di Lorenzo R, Bernardi M, Genedani S, Zirilli E, Grossi G, Guaraldi GP, Bertolini A. Acute alkalosis, but not acute hypocalcemia, increases panic behavior in an animal model. Physiol Behav. 1987;41(4):357-60. doi: 10.1016/0031-9384(87)90401-x.

  PMID: 2829248 BACKGROUND

• Roberts GE, Heeley AF. Tryptophan metabolism in psychotic children. Dev Med Child Neurol. 1968 Oct;10(5):681. No abstract available.

  PMID: 5708291 BACKGROUND

• Wang ZJ, Ohliger MA, Larson PEZ, Gordon JW, Bok RA, Slater J, Villanueva-Meyer JE, Hess CP, Kurhanewicz J, Vigneron DB. Hyperpolarized 13C MRI: State of the Art and Future Directions. Radiology. 2019 May;291(2):273-284. doi: 10.1148/radiol.2019182391. Epub 2019 Mar 5.

  PMID: 30835184 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Oncologic Imaging

Model Details: Participants will be evaluated pre and post hyperpolarized 13-C pyruvate injection for change in pyruvate signal compared to background.

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 25, 2023
• Study Start: June 24, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)