NCT05041166

Brief 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. For (n=5) volunteers undergoing brain imaging we will compare the standard injection at 5mL/second with a slower infusion (0.1-1mL/second) to achieve a 60 second infusion time, to approach quasi steady-state metabolism and improve SNR.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
4mo left

Started Sep 2021

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Sep 2021Sep 2026

Study Start

First participant enrolled

September 1, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 10, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

5 years

First QC Date

September 2, 2021

Last Update Submit

February 18, 2026

Conditions

Healthy Volunteers

Keywords

MRIHyperpolarized (HP) [13C] pyruvate21-309

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Protocol optimization cohort

EXPERIMENTAL

Following the \[13C\]pyruvate injection, dynamic imaging and 3D volumetric imaging of volunteers in the first cohort (HP MRI protocol optimization, Aim 1) will be performed on the 3-T MRI scanner, using different \[13C\] RF excitation/detection coils.

Drug: Hyperpolarized [13C] Pyruvate

Tissue reference cohort

EXPERIMENTAL

The optimal setup will then be used for HP MRI of the second cohort.

Drug: Hyperpolarized [13C] Pyruvate

Interventions

Hyperpolarized [13C] PyruvateDRUG

Will be injected at a dosage of 0.43 ± 0.05 mL/kg body weight

Protocol optimization cohortTissue reference cohort

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Interventions

Pyruvic Acid

Intervention Hierarchy (Ancestors)

PyruvatesKeto AcidsCarboxylic AcidsOrganic Chemicals

Study Officials

  • Vesselin Miloushev, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: This in-human study of HP \[13C\]pyruvate MRI at MSKCC will be an open-label study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2021

First Posted

September 10, 2021

Study Start

September 1, 2021

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Locations

US(1)