HC-MRI: HP Pyruvate MRI in Cancers

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05697406
Collaborator
(none)
25
1
1
60
0.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Hyperpolarized 13C-Pyruvate
Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
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.Participants will be evaluated pre and post hyperpolarized 13-C pyruvate injection for change in pyruvate signal compared to background.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Hyperpolarized 13-C Pyruvate MRI Surveillance of Multiple Cancers
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2026
Anticipated Study Completion Date :
Feb 1, 2028

Arms and Interventions

Arm Intervention/Treatment
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
Imaging tumors pre and post administration of hyperpolarized 13-C pyruvate injection.

Outcome Measures

Primary Outcome Measures

  1. Pyruvate to Lactate Conversion [18-36 months]

    Imaging Quality, KpL

Secondary Outcome Measures

  1. SNR [12-42 months]

    Signal to Noise Ratio, dB

  2. CNR [12-42 months]

    Contrast to Noise

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 88 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Clinical tumor diagnosis

Patients with pre-existing MR imaging appointments

Must be able to undergo MR

Exclusion Criteria:

No tumor diagnosis

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Maryland Medical Center Baltimore Maryland United States 21201

Sponsors and Collaborators

  • University of Maryland, Baltimore

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Vikas Kundra, Chief of Oncologic Imaging, University of Maryland, Baltimore
ClinicalTrials.gov Identifier:
NCT05697406
Other Study ID Numbers:
  • HP-00101177
First Posted:
Jan 25, 2023
Last Update Posted:
Feb 1, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 1, 2023