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Trial Title: HP Pyruvate MRI in Cancers

NCT ID: NCT05697406

Condition: Image
Warburg Effect
Tumors

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

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

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Hyperpolarized 13C-Pyruvate
Description: Imaging tumors pre and post administration of hyperpolarized 13-C pyruvate injection.
Arm group label: Experimental

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.

Detailed description: 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: Clinical tumor diagnosis Patients with pre-existing MR imaging appointments Must be able to undergo MR Exclusion Criteria: No tumor diagnosis

Gender: All

Minimum age: 18 Years

Maximum age: 88 Years

Healthy volunteers: No

Locations:

Facility:
Name: University of Maryland Medical Center

Address:
City: Baltimore
Zip: 21201
Country: United States

Status: Recruiting

Contact:
Last name: Rosy Njonkou, MA

Phone: 443-365-0701
Email: rnjonkou@som.umaryland.edu

Start date: June 24, 2024

Completion date: December 1, 2028

Lead sponsor:
Agency: University of Maryland, Baltimore
Agency class: Other

Source: University of Maryland, Baltimore

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05697406

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