HP Pyruvate MRI in Cancers

Tumors Clinical Trial

— HC-MRI  

Official title:

Hyperpolarized 13-C Pyruvate MRI Surveillance of Multiple Cancers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05697406
• Other study ID #: HP-00101177
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: June 1, 2024
• Est. completion date: December 1, 2028

Study information

• Verified date: February 2024
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: December 1, 2028
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

Inclusion Criteria:

Clinical tumor diagnosis

Patients with pre-existing MR imaging appointments

Must be able to undergo MR

Exclusion Criteria:

No tumor diagnosis

Related Conditions & MeSH terms

• Image
• Tumors

Intervention

Drug:
• Hyperpolarized 13C-Pyruvate
Imaging tumors pre and post administration of hyperpolarized 13-C pyruvate injection.

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

References & Publications (3)

Albers MJ, Bok R, Chen AP, Cunningham CH, Zierhut ML, Zhang VY, Kohler SJ, Tropp J, Hurd RE, Yen YF, Nelson SJ, Vigneron DB, Kurhanewicz J. Hyperpolarized 13C lactate, pyruvate, and alanine: noninvasive biomarkers for prostate cancer detection and grading. Cancer Res. 2008 Oct 15;68(20):8607-15. doi: 10.1158/0008-5472.CAN-08-0749. — View Citation

Ravoori MK, Singh SP, Lee J, Bankson JA, Kundra V. In Vivo Assessment of Ovarian Tumor Response to Tyrosine Kinase Inhibitor Pazopanib by Using Hyperpolarized 13C-Pyruvate MR Spectroscopy and 18F-FDG PET/CT Imaging in a Mouse Model. Radiology. 2017 Dec;285(3):830-838. doi: 10.1148/radiol.2017161772. Epub 2017 Jul 13. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pyruvate to Lactate Conversion	Imaging Quality, KpL	18-36 months
Secondary	SNR	Signal to Noise Ratio, dB	12-42 months
Secondary	CNR	Contrast to Noise	12-42 months