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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