Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-02-26 @ 12:42 AM
Study NCT ID:
NCT02390635
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-03
First Post:
2015-03-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PET/MRI, 18F-FDG PET/CT and Whole Body MRI in Finding Extramedullary Myeloid Leukemia in Patients With Newly Diagnosed Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D015473', 'term': 'Leukemia, Promyelocytic, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019788', 'term': 'Fluorodeoxyglucose F18'}, {'id': 'D005682', 'term': 'Gadolinium'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D028581', 'term': 'Lanthanoid Series Elements'}, {'id': 'D008674', 'term': 'Metals, Rare Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D008670', 'term': 'Metals'}, {'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': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-31', 'studyFirstSubmitDate': '2015-03-11', 'studyFirstSubmitQcDate': '2015-03-11', 'lastUpdatePostDateStruct': {'date': '2025-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of extramedullary myeloid leukemia (EML)', 'timeFrame': 'At time of imaging', 'description': 'Defined as increased fludeoxyglucose F-18 uptake on positron emission tomography (PET)/computed tomography and increased signal on T2 weighted imaging or diffusion weighted imaging and enhancement in soft tissue on whole body PET/magnetic resonance imaging. Estimates and 95% confidence intervals for the incidence of EML will be reported for each imaging modality based on the exact Clopper-Pearson method.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia', 'Acute Promyelocytic Leukemia With PML-RARA']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'This pilot phase I trial studies how well positron emission tomography (PET)/magnetic resonance imaging (MRI), fludeoxyglucose F-18 (18F-FDG) PET/computed tomography (CT), and whole body MRI work in finding extramedullary myeloid leukemia in patients with newly diagnosed acute myeloid leukemia. Extramedullary myeloid leukemia is a type of cancer found outside of the bone marrow and can be hard to detect with routine bone marrow monitoring, such as bone marrow aspirations. Diagnostic procedures, such as PET/MRI, 18F-FDG PET/CT and whole body MRI, may help find and diagnose extramedullary myeloid leukemia in patients with newly diagnosed acute myeloid leukemia.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To estimate the incidence of extramedullary myeloid leukemia (EML) in patients with newly diagnosed acute myeloid leukemia (AML), including acute promyelocytic leukemia (APL), by imaging criteria using PET/MR (magnetic resonance), whole body MR, and PET/CT.\n\nSECONDARY OBJECTIVES:\n\nI. To qualitatively and quantitatively assess PET/MR and PET/CR that will be performed with and without fiducial markers, and to correlate these findings with clinical outcomes of treatment response, relapse, and patterns of relapse.\n\nII. Correlate findings of EML as in the primary objectives with clinical outcomes of treatment response, relapse, and patterns of relapse including location of relapse compared to site of EML.\n\nOUTLINE:\n\nPatients receive gadolinium intravenously (IV) and undergo whole body PET/MRI comprising diffusion weighted imaging and 3-dimentional (3D) fast spoiled gradient echo dual echo (FSPGR-DE) with and without fiducial markers. Patients then undergo 18F-FDG PET/CT before start treatment for acute myeloid leukemia.\n\nAfter completion of study, patients are followed up periodically.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with newly diagnosed AML\n* Non-English speaking subjects will be included. Verbal Translation Preparative Sheet (VTPS) short form will be utilized in consenting non-English speaking subjects.\n\nExclusion Criteria:\n\n* Patients with contraindications to MR\n* Patients with a known allergy to MR contrast agents\n* Uncontrollable claustrophobia\n* Recipients of more than minimal anti-leukemia treatment, with minimal treatment defined as: leukapheresis, hydroxyurea, or Cytarabine more than 1 g per square meter.\n* Patients with secondary or relapsed AML or APL should be excluded.\n* Patients with known extramedullary leukemia\n* Positive pregnancy test in a female of childbearing potential\n* Younger than 18 years\n* Greater than 400 pounds in weight\n* Patients with uncontrolled diabetes\n* Cognitive impaired adults or prisoners will be excluded\n* Estimated glomerular filtration rate (eGFR \\<30) will be excluded'}, 'identificationModule': {'nctId': 'NCT02390635', 'briefTitle': 'PET/MRI, 18F-FDG PET/CT and Whole Body MRI in Finding Extramedullary Myeloid Leukemia in Patients With Newly Diagnosed Acute Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'PET/MR, PET/CT and Whole Body MR in Newly Diagnosed Acute Myeloid Leukemia (AML)', 'orgStudyIdInfo': {'id': '2014-0616'}, 'secondaryIdInfos': [{'id': 'NCI-2015-00525', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2014-0616', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (18F-FDG PET/CT, whole body PET/MRI)', 'description': 'Patients receive gadolinium IV and undergo whole body PET/MRI comprising diffusion weighted imaging and 3D FSPGR-DE with and without fiducial markers. Patients then undergo 18F-FDG PET/CT before start treatment for acute myeloid leukemia.', 'interventionNames': ['Procedure: Computed Tomography', 'Procedure: Diffusion Weighted Imaging', 'Radiation: Fludeoxyglucose F-18', 'Drug: Gadolinium', 'Procedure: Magnetic Resonance Imaging', 'Procedure: Positron Emission Tomography', 'Procedure: Three-Dimensional Spoiled Gradient MRI']}], 'interventions': [{'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT', 'CAT Scan', 'Computerized Axial Tomography', 'computerized tomography', 'CT', 'CT SCAN', 'tomography'], 'description': 'Undergo 18F-FDG PET/CT', 'armGroupLabels': ['Diagnostic (18F-FDG PET/CT, whole body PET/MRI)']}, {'name': 'Diffusion Weighted Imaging', 'type': 'PROCEDURE', 'otherNames': ['Diffusion Weighted MRI', 'Diffusion-Weighted Magnetic Resonance Imaging', 'Diffusion-Weighted MR Imaging', 'Diffusion-Weighted MRI', 'DW-MRI', 'DWI', 'DWI MRI', 'DWI-MRI', 'MR Diffusion-Weighted Imaging'], 'description': 'Undergo whole body PET/MRI', 'armGroupLabels': ['Diagnostic (18F-FDG PET/CT, whole body PET/MRI)']}, {'name': 'Fludeoxyglucose F-18', 'type': 'RADIATION', 'otherNames': ['18FDG', 'FDG', 'Fludeoxyglucose (18F)', 'fludeoxyglucose F 18', 'Fludeoxyglucose F18', 'Fluorine-18 2-Fluoro-2-deoxy-D-Glucose', 'Fluorodeoxyglucose F18'], 'description': 'Undergo 18F-FDG PET/CT', 'armGroupLabels': ['Diagnostic (18F-FDG PET/CT, whole body PET/MRI)']}, {'name': 'Gadolinium', 'type': 'DRUG', 'otherNames': ['Gd'], 'description': 'Given IV', 'armGroupLabels': ['Diagnostic (18F-FDG PET/CT, whole body PET/MRI)']}, {'name': 'Magnetic Resonance Imaging', 'type': 'PROCEDURE', 'otherNames': ['Magnetic Resonance Imaging Scan', 'Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance', 'MR Imaging', 'MRI', 'MRI Scan', 'NMR Imaging', 'NMRI', 'Nuclear Magnetic Resonance Imaging'], 'description': 'Undergo whole body PET/MRI', 'armGroupLabels': ['Diagnostic (18F-FDG PET/CT, whole body PET/MRI)']}, {'name': 'Positron Emission Tomography', 'type': 'PROCEDURE', 'otherNames': ['Medical Imaging, Positron Emission Tomography', 'PET', 'PET Scan', 'Positron Emission Tomography Scan', 'Positron-Emission Tomography', 'proton magnetic resonance spectroscopic imaging'], 'description': 'Undergo 18F-FDG PET/CT and whole body PET/MRI', 'armGroupLabels': ['Diagnostic (18F-FDG PET/CT, whole body PET/MRI)']}, {'name': 'Three-Dimensional Spoiled Gradient MRI', 'type': 'PROCEDURE', 'otherNames': ['3-Dimensional Fast Spoiled Gradient', '3D Fast Spoiled Gradient Recalled MRI', '3D FSPGR', '3DFSPGR', 'FSPGR', 'FSPGR MRI', 'SPGR', 'SPGR MRI', 'Three-Dimensional Spoiled Gradient-Echo MR'], 'description': 'Undergo whole body PET/MRI', 'armGroupLabels': ['Diagnostic (18F-FDG PET/CT, whole body PET/MRI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], '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'}}}}