Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-01 @ 1:40 PM
Study NCT ID:
NCT04772456
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2021-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyperpolarized 13C-pyruvate Metabolic MRI With Infiltrating Gliomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2021-02-23', 'studyFirstSubmitQcDate': '2021-02-23', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of metabolic MRI to diagnose Glioma', 'timeFrame': 'Within three years post treatment', 'description': 'To study the accuracy of hyperpolarized metabolic MRI to diagnose Glioma Cancer. We will compare the prediction of cancer from the MRI scan compared to actual diagnosis of cancer by any subsequent workup or procedure the participant undergoes. Prediction of cancer from MRI scan will be performed by assigning a standardized score . Actual diagnosis of cancer will be based on tissue pathology.'}], 'secondaryOutcomes': [{'measure': 'Utility of metabolic MRI over standard MRI imaging in the diagnosis of Glioma cancer', 'timeFrame': 'Within three years post treatment', 'description': "To examine the added utility of metabolic MRI over standard MRI imaging. 3. We will quantify the number of participants in which the MRI provided extra information that otherwise was not available during the course of the patient's workup."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glioma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the safety and feasibility of performing hyperpolarized metabolic MRI in the diagnosis of brain tumor. This study will also assess the accuracy of hyperpolarized metabolic MRI to diagnose intermediate to patients with infiltrating gliomas and examine the added utility of metabolic MRI over standard MRI imaging\n\nThe FDA is allowing the use of hyperpolarized \\[1-13C\\] pyruvate (HP 13C-pyruvate) in this study.\n\nUp to 5 patients may take part in this study at the University of Maryland, Baltimore (UMB).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Patients with a new brain lesion interpreted as suspected infiltrating gliomas including but not limited to (diffuse astrocytoma WHO grade 2; oligodendroglioma WHO grade 2 and 3; anaplastic astrocytoma WHO grade 3; astrocytoma WHO grade 4), OR, patients with prior history of infiltrating glioma scheduled for surgery for tumor biopsy or resection.\n\n * Ages 18-80, including male and female\n * Suitable to undergo contrast-enhanced MRI\n * Negative serum pregnancy test\n\nExclusion Criteria:\n\n* Inability to undergo MRI scan\n* Inability to receive IV contrast secondary to severe reaction or renal insufficiency.'}, 'identificationModule': {'nctId': 'NCT04772456', 'briefTitle': 'Hyperpolarized 13C-pyruvate Metabolic MRI With Infiltrating Gliomas', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Correlation of Hyperpolarized 13C-pyruvate Metabolic Magnetic Resonance Imaging and Tumor Histopathology in Patients With Infiltrating Gliomas', 'orgStudyIdInfo': {'id': 'HP-00086612'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'metabolic MRI', 'description': 'Single-arm study in patients who have Glioma Perform metabolic magnetic resonance imaging on patient have a Glioma cancer to understand if metabolic MRI can be safely performed on this population', 'interventionNames': ['Drug: Hyperpolarized 13C-Pyruvate']}], 'interventions': [{'name': 'Hyperpolarized 13C-Pyruvate', 'type': 'DRUG', 'description': 'Hyperpolarized Pyruvate (13C) Injection, containing spin-polarized ("hyperpolarized") \\[ 13C\\]pyruvate, is being studied as a diagnostic agent in combination with 13C spectroscopic MR imaging. The aim is to visualize \\[13C\\]pyruvate and its metabolites and thereby distinguish between anatomical areas with normal vs. abnormal metabolism, which should be useful in diagnosing and characterizing, for example, malignancy.\n\nHyperpolarized Pyruvate (13C) Injection and \\[13C\\]pyruvate are general terms used throughout this brochure, that refer to all 13C labeling patterns, such as \\[1- 13C\\]pyruvate, \\[2- 13C\\]pyruvate and \\[1,2- 13C\\]pyruvate. From biological and safety standpoints, pyruvate with each of the labeling patterns behaves identically in the human body \\[Koletzko et al., 1997\\].', 'armGroupLabels': ['metabolic MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rosy Njonkou Tchoquessi', 'role': 'CONTACT', 'email': 'rnjonkou@som.umaryland.edu', 'phone': '4107066445'}], 'facility': 'Rosy Njonkou Tchoquessi', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Rosy Njonkou Tchoquessi', 'role': 'CONTACT', 'email': 'rnjonkou@som.umaryland.edu', 'phone': '4107066445'}], 'overallOfficials': [{'name': 'Dirk Mayer, Dr. rer. nat', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland, Baltimore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dirk Mayer', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}