Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-27 @ 9:33 AM
Study NCT ID:
NCT05041166
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-27
First Post:
2021-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of [13C]Pyruvate as an Imaging Agent for Magnetic Resonance Imaging in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019289', 'term': 'Pyruvic Acid'}], 'ancestors': [{'id': 'D011773', 'term': 'Pyruvates'}, {'id': 'D007651', 'term': 'Keto Acids'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This in-human study of HP \\[13C\\]pyruvate MRI at MSKCC will be an open-label study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2021-09-02', 'studyFirstSubmitQcDate': '2021-09-02', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Signal-to-noise ratios', 'timeFrame': '1 day', 'description': 'will be used to assess image quality, and to compare the different technical setups. The setup providing the highest SNR will be considered optimal.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MRI', 'Hyperpolarized (HP) [13C] pyruvate', '21-309'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/mskcc/html/44.cfm', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFifty healthy volunteers will be included.\n\n* Age between 18-80\n* 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.\n\nExclusion Criteria:\n\n* Breast-feeding\n* History of metabolic (e.g. diabetes) and renal functional disorders.\n* Refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia)\n* Acute major illness (e.g., unstable cardiovascular condition, systemic malignant diseases, etc.).\n* 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.'}, 'identificationModule': {'nctId': 'NCT05041166', 'briefTitle': 'A Study of [13C]Pyruvate as an Imaging Agent for Magnetic Resonance Imaging in Healthy Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Optimized In-Human [13C]Pyruvate MRI For Assessment Of Physiologic Reference Data In Different Organs', 'orgStudyIdInfo': {'id': '21-309'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Protocol optimization cohort', 'description': '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.', 'interventionNames': ['Drug: Hyperpolarized [13C] Pyruvate']}, {'type': 'EXPERIMENTAL', 'label': 'Tissue reference cohort', 'description': 'The optimal setup will then be used for HP MRI of the second cohort.', 'interventionNames': ['Drug: Hyperpolarized [13C] Pyruvate']}], 'interventions': [{'name': 'Hyperpolarized [13C] Pyruvate', 'type': 'DRUG', 'description': 'Will be injected at a dosage of 0.43 ± 0.05 mL/kg body weight', 'armGroupLabels': ['Protocol optimization cohort', 'Tissue reference cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Vesselin Miloushev, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}