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NCT05041166 Clinical Trial

A Study of [13C]Pyruvate as an Imaging Agent for Magnetic Resonance Imaging in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:
Optimized In-Human [13C]Pyruvate MRI For Assessment Of Physiologic Reference Data In Different Organs

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05041166
Other study ID # 21-309
Secondary ID
Status Enrolling by invitation
Phase Phase 1
First received
Last updated
Start date September 1, 2021
Est. completion date September 2025

Study information
Verified date September 2023
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to learn about the use of [13C]pyruvate as an imaging agent for MRI scans. In past studies, researchers have seen that [13C]pyruvate can improve imaging with MRI scans. However, they would like to know more about how the imaging agent is distributed in healthy organs and tissues. This study will provide additional information about the use of [13C]pyruvate as an imaging agent for MRI scans, and it will show us how the substance is metabolized (changed into energy) in the organs and tissues of healthy volunteers.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 50
Est. completion date September 2025
Est. primary completion date September 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: Fifty healthy volunteers will be included. - Age between 18-80 - Negative serum or urine pregnancy test for female volunteers of childbearing age and potential (as defined by MSKCC Standards & Guidelines), from assays obtained <2 weeks prior to study enrollment. Urine pregnancy tests are only valid for the day of test. Exclusion Criteria: - Breast-feeding - History of metabolic (e.g. diabetes) and renal functional disorders. - Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia) - Acute major illness (e.g., unstable cardiovascular condition, systemic malignant diseases, etc.). - Standard MRI safety screening will be applied (MRI screening questionnaire); volunteers with MR unsafe devices, or conditional devices where research mode is not allowed, will be excluded.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Hyperpolarized [13C] Pyruvate
Will be injected at a dosage of 0.43 ± 0.05 mL/kg body weight

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (2)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Signal-to-noise ratios will be used to assess image quality, and to compare the different technical setups. The setup providing the highest SNR will be considered optimal. 1 day
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