Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-01-04 @ 5:39 PM
Study NCT ID:
NCT03830151
Status:
RECRUITING
Last Update Posted:
2025-07-30
First Post:
2019-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 13}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2019-02-01', 'studyFirstSubmitQcDate': '2019-02-04', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful collection of hyperpolarized pyruvate magnetic resonance (MR) (HMR) imaging data', 'timeFrame': 'Up to 1 year', 'description': 'The kpl values will be calculated for each biopsy site, tumor border zone, and the contralateral side.'}], 'secondaryOutcomes': [{'measure': 'Ki-67 quantitation', 'timeFrame': 'Up to 1 year', 'description': "Spearman's rank correlation will be used to assess the association between kpl values and Ki-67 if the samples are assumed to be independent. Otherwise, intraclass correlation coefficient (ICC) of random effects models will be used."}, {'measure': 'Tumor kpl values', 'timeFrame': 'Up to 1 year', 'description': 'Will compare with normal brain kpl values. Linear mixed models will be used.'}, {'measure': 'Normal brain kpl values', 'timeFrame': 'Up to 1 year', 'description': 'Will compare with tumor kpl values. Linear mixed models will be used.'}, {'measure': 'Pathology results', 'timeFrame': 'Up to 1 year', 'description': 'Correlation with kpl values will be determined through generalized linear mixed models.'}, {'measure': 'MR imaging findings', 'timeFrame': 'Up to 1 year', 'description': 'Correlation with kpl values will be determined through generalized linear mixed models.'}, {'measure': 'Genomic findings', 'timeFrame': 'Up to 1 year', 'description': 'Correlation with kpl values will be determined through generalized linear mixed models.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Brain Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'This trial studies how an imaging agent, hyperpolarized carbon C 13 pyruvate, works in diagnosing glioma in patients with brain tumors. Giving hyperpolarized carbon C 13 pyruvate before an advanced imaging technique called a magnetic resonance spectroscopic imaging (MRSI) scan may help researchers better diagnose glioma in patients with brain tumors.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To establish a clinical infrastructure for performing hyperpolarized carbon C 13 pyruvate (hyperpolarized 13-C-pyruvate) imaging in the human brain at MD Anderson.\n\nSECONDARY OBJECTIVES:\n\nI. To assess the correlation between conversion rate of hyperpolarized pyruvate to lactate (kpl) values and Ki-67 quantitation in the tumor.\n\nII. To compare kpl values between tumor and normal brain within patient. III. To assess the association between kpl values and pathology results, including conventional, diffusion, perfusion, and permeability imaging.\n\nIV. To assess the association between kpl values and magnetic resonance (MR) imaging findings.\n\nV. To assess the association between kpl values and genomic findings, including methylation, ribonucleic acid \\[RNA\\], and deoxyribonucleic acid \\[DNA\\]).\n\nOUTLINE:\n\nPatients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over 10-20 seconds and then undergo an MRSI scan.\n\nAfter completion of study, patients are followed up for 1 day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent will be obtained from each participants including healthy volunteers.\n* Healthy volunteers will not have contra-indications to MR scanning, but will otherwise not be subject to other selection criteria.\n* All patients will be enrolled in study # 2011-0370, the Stereotactic RadPath trial\n* Patient is \\>18 years old, agrees to participate in the clinical study and to complete all required visits and evaluations. The pediatric population has a different disease profile from the glioma patients we hope to recruit. To reduce heterogeneity in the patient population we will not consider patients younger than 18 for this study.\n* Patient is a candidate for cerebral tumor resection with lesion suspected to be or previously biopsy proven to be a primary brain tumor.\n* Patient is able to understand and give consent to participation in the study.\n* Patient agrees to undergo, prior to the procedure, magnetic resonance imaging (MRI, within 14 days and preferably with 3 days of the planned procedure) with perfusion, diffusion and spectroscopic imaging.\n* Patient has a GFR \\> 60. In patients with moderate renal failure (GFR 30-60), an alternate injection with 2 times half-dose multihance (gadobenate dimeglumine) or gadovist (gadobutrol) will be considered, if a contrast exam is deemed clinically necessary.\n* Specifically for this Study: Patient is willing to give signed informed consent for C13-Pyruvate MR Spectroscopy.\n\nExclusion Criteria:\n\n* Healthy volunteers will be screened using same process but will otherwise not be subject to other selection criteria.\n* The patient is found to have unfavorable anatomy to indicate that stereotactic biopsy could not be safely performed.\n* Pacemakers, electronic stimulation, metallic foreign bodies and devices and/or other conditions that are not MR safe, which include but are not limited to: • electronically, magnetically, and mechanically activated implants • ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators and cardiac pacemakers • metallic splinters in the eye • ferromagnetic hemostatic clips in the central nervous system (CNS) or body • cochlear implants • other pacemakers, e.g., for the carotid sinus • insulin pumps and nerve stimulators • non-MR safe lead wires • prosthetic heart valves (if dehiscence is suspected) • non-ferromagnetic stapedial implants • pregnancy • claustrophobia that does not readily respond to oral medication\n* Prior brain tumor treatment, including surgical resection, radiation therapy or chemotherapy for a primary brain neoplasm. Previous biopsy will not disqualify the patient from participation. Remote history (\\> 6month) of non-CNS malignancy in remission, without evidence of current/ prior brain metastasis, will also not disqualify patient from participating.\n* History of cardiac arrhythmia'}, 'identificationModule': {'nctId': 'NCT03830151', 'briefTitle': 'Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Hyperpolarized Pyruvate Imaging of Glioma: Imaging-Pathological Correlation', 'orgStudyIdInfo': {'id': '2018-0902'}, 'secondaryIdInfos': [{'id': 'NCI-2019-00007', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2018-0902', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (carbon C 13 pyruvate, MRSI)', 'description': 'Patients receive hyperpolarized carbon C 13 pyruvate IV over 10-20 seconds and then undergo an MRSI scan.', 'interventionNames': ['Drug: Hyperpolarized Carbon C 13 Pyruvate', 'Procedure: Magnetic Resonance Spectroscopic Imaging']}], 'interventions': [{'name': 'Hyperpolarized Carbon C 13 Pyruvate', 'type': 'DRUG', 'otherNames': ['Hyperpolarized 13C-Pyruvate', 'Hyperpolarized Pyruvate (13C)'], 'description': 'Given IV', 'armGroupLabels': ['Diagnostic (carbon C 13 pyruvate, MRSI)']}, {'name': 'Magnetic Resonance Spectroscopic Imaging', 'type': 'PROCEDURE', 'otherNames': ['1H- Nuclear Magnetic Resonance Spectroscopic Imaging', '1H-nuclear magnetic resonance spectroscopic imaging', 'Magnetic Resonance Spectroscopy', 'MRS', 'MRS Imaging', 'MRSI', 'Proton Magnetic Resonance Spectroscopic Imaging'], 'description': 'Undergo MRSI', 'armGroupLabels': ['Diagnostic (carbon C 13 pyruvate, MRSI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dawid Schellingerhout', 'role': 'CONTACT', 'phone': '713-794-5673'}, {'name': 'Dawid Schellingerhout', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Dawid Schellingerhout', 'role': 'CONTACT', 'email': 'dawid.schellingerhout@mdanderson.org', 'phone': '713-794-5673'}], 'overallOfficials': [{'name': 'Dawid Schellingerhout', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}