Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-02-26 @ 2:18 AM
Study NCT ID:
NCT02682732
Status:
UNKNOWN
Last Update Posted:
2018-02-22
First Post:
2016-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Imaging to Capture Disease Heterogeneity in Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-20', 'studyFirstSubmitDate': '2016-02-03', 'studyFirstSubmitQcDate': '2016-02-10', 'lastUpdatePostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with heterogeneous (positron-emission tomography) PET/CT activity before induction chemotherapy', 'timeFrame': 'Up to 3 years'}], 'secondaryOutcomes': [{'measure': 'Number of patients with residual (positron-emission tomography) PET/CT activity following induction chemotherapy', 'timeFrame': 'Up to 3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Myeloid Leukemia', 'PET/CT Scan'], 'conditions': ['Leukemia, Myeloid, Acute']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.nlm.nih.gov/medlineplus/acutemyeloidleukemia.html', 'label': 'Acute Myeloid Leukemia'}, {'url': 'https://www.nlm.nih.gov/medlineplus/ency/article/003827.htm', 'label': 'PET Scan'}]}, 'descriptionModule': {'briefSummary': 'The current understanding of acute myeloid leukemia (AML) is that one site of bone marrow (BM) sampling serves as a window that represents all AML cells distributed throughout the BM, an assumption that has yet to be questioned. Simulation in mice led to inconsistent representation of the full BM, which can incorrectly suggest the absence of leukemic cells. Positron-emission tomography (PET) scan can detect areas of high metabolic activity in the body using for instance a radioactive sugar. In one report, its use in human AML has provided proof-of-principle evidence of unequal distribution of AML cells in BM. Accordingly, the alternative hypothesis is to test if PET scan can demonstrate if BM geography can alter AML cells spread and home them as distinct areas rather than uniform spread as if they are distributed in liquid state.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New diagnosis of AML according to the WHO (World Health Organization) criteria\n\nExclusion Criteria:\n\n* Prior malignancy, unless the patient has been disease-free for at least five years following curative intent therapy, with the following exceptions: patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, if definitive treatment for the condition has been completed; or patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease.\n* Acute promyelocytic leukemia (APL).\n* ECOG (Eastern Cooperative Oncology Group) performance status of 3 or more\n* Inadequate renal function (i.e., estimated GFR (glomerular filtration rate) \\< 60 mL/min/1.73m2).\n* Inadequate hepatic function (i.e., serum bilirubin \\> 1.5×ULN; AST (aspartate aminotransferase), ALT (alanine aminotransferase) and ALP (alkaline phosphatase) \\> 2.5×ULN)\n* Presence of uncontrolled systemic fungal, bacterial, viral or other infections (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).\n* Having any other severe concurrent disease or serious organ dysfunction that may place the patient at undue risk to receive induction therapy.\n* Pregnancy or lactating female.'}, 'identificationModule': {'nctId': 'NCT02682732', 'briefTitle': 'Molecular Imaging to Capture Disease Heterogeneity in Acute Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Hamilton Health Sciences Corporation'}, 'officialTitle': 'Molecular Imaging to Capture Disease Heterogeneity in Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': 'NIF-15378'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FDG-PET/CT', 'description': '(Fluorodeoxyglucose positron-emission tomography) FDG-PET/CT guided bone marrow sampling will be performed at diagnosis and at the end of induction chemotherapy (like cytarabine and daunorubicin). Then, patients will be followed to assess their response, and imaging-guided bone marrow sampling will be repeated in the likely event of disease relapse.', 'interventionNames': ['Procedure: FDG-PET/CT guided bone marrow sampling']}], 'interventions': [{'name': 'FDG-PET/CT guided bone marrow sampling', 'type': 'PROCEDURE', 'description': '(Fluorodeoxyglucose positron-emission tomography) FDG-PET/CT guided bone marrow sampling will be used to obtain two different samples from avid and dim bone marrow areas.', 'armGroupLabels': ['FDG-PET/CT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hamilton', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Mohammed Almakadi, MBBS', 'role': 'CONTACT', 'email': 'almakams@mcmaster.ca'}, {'name': 'Mohammed Almakadi, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Juravinski Hospital and Cancer Center', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'centralContacts': [{'name': 'Mohammed Almakadi, MBBS', 'role': 'CONTACT', 'email': 'almakams@mcmaster.ca', 'phone': '905-525-9140', 'phoneExt': '21872'}], 'overallOfficials': [{'name': 'Mickie Bhatia, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'McMaster University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data will be shared after the study is completed'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MBBS, FRCP(C)', 'investigatorFullName': 'Mohammed Almakadi', 'investigatorAffiliation': 'Hamilton Health Sciences Corporation'}}}}