Healthy VolunteersPhase 1NCT05041166
A Study of [13C]Pyruvate as an Imaging Agent for Magnetic Resonance Imaging in Healthy Volunteers
A Phase 1 study testing Hyperpolarized [13C] Pyruvate in people with Healthy Volunteers, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Hyperpolarized [13C] Pyruvate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Optimized In-Human [13C]Pyruvate MRI For Assessment Of Physiologic Reference Data In Different Organs
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.
- Conditions
- Healthy Volunteers
- Being tested
- Hyperpolarized [13C] Pyruvate
- Keywords
- MRI, Hyperpolarized (HP) [13C] pyruvate, 21-309
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarized [13C] PyruvateDrug
Will be injected at a dosage of 0.43 ± 0.05 mL/kg body weight
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Hyperpolarized [13C] Pyruvate |
| Tissue reference cohort | Experimental | The optimal setup will then be used for HP MRI of the second cohort. Receives: Drug: Hyperpolarized [13C] Pyruvate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start1 Sep 2021
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This in-human study of HP \[13C\]pyruvate MRI at MSKCC will be an open-label study.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Responsible party
- Sponsor
- Investigators
- Vesselin Miloushev, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041166
- Sponsor's protocol ID
- 21-309
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2021
- Last updated
- 2 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized In-Human [13C]Pyruvate MRI For Assessment Of Physiologic Reference Data In Different Organs
- ClinicalTrials.gov ID
- NCT05041166
- Acronym / sponsor ID
- 21-309
- Conditions
- Healthy Volunteers
- Keywords
- MRI, Hyperpolarized (HP) [13C] pyruvate, 21-309
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This in-human study of HP [13C]pyruvate MRI at MSKCC will be an open-label study.
| Arm | Type | Receives |
|---|---|---|
| Protocol optimization cohort | Experimental | Drug: Hyperpolarized [13C] PyruvateFollowing 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. |
| Tissue reference cohort | Experimental | Drug: Hyperpolarized [13C] PyruvateThe optimal setup will then be used for HP MRI of the second cohort. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperpolarized [13C] PyruvateWill be injected at a dosage of 0.43 ± 0.05 mL/kg body weight | Drug | Protocol optimization cohort, Tissue reference cohort |
Primary outcome
Signal-to-noise ratios
Time frame: 1 day
will be used to assess image quality, and to compare the different technical setups. The setup providing the highest SNR will be considered optimal.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vesselin Miloushev, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hyperpolarized [13C] Pyruvate in people with Healthy Volunteers, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Signal-to-noise ratios (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.