Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-29 @ 6:29 PM
Study NCT ID:
NCT01592266
Status:
UNKNOWN
Last Update Posted:
2012-05-07
First Post:
2012-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
F18-FLT PET/CT as a Tool for Assessment of Myeloablative Treatment in Patients With Acute Myeloid Leucemia(AML)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'lastUpdateSubmitDate': '2012-05-03', 'studyFirstSubmitDate': '2012-04-16', 'studyFirstSubmitQcDate': '2012-05-03', 'lastUpdatePostDateStruct': {'date': '2012-05-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of extent and intensity ( by standardized uptake value - SUV) of disease in bone marrow demonstrated on PET/CT images before and after treatment.'}], 'secondaryOutcomes': [{'measure': 'prediction of treatment response by dynamics of FLT uptake(by SUV)in comparison to bone marrow biopsy'}]}, 'conditionsModule': {'keywords': ['FLT', 'PET', 'bone marrow', 'AML'], 'conditions': ['Acute Myeloid Leucemia']}, 'descriptionModule': {'briefSummary': 'PET/CT is reliable tool in evaluation of treatment response in number cancers. F18-FLT is a precursor of DNA with high uptake in the bone marrow as a part of normal biodistribution. Highly increased uptake of this radiopharmaceutical was shown in a number of hematologic disease either in bone marrow or extramedullary.\n\nF18-FLT PET/CT can provide a tool for whole body assessment of activity in bone marrow as well as early estimation of treatment efficacy or lack of it. In addition, this noninvasive study can replace bone marrow biopsy and predict response vs. non response to therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with new diagnosis of AML', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* new diagnosis of AML\n\nExclusion Criteria:\n\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01592266', 'acronym': 'AML F18-FLT', 'briefTitle': 'F18-FLT PET/CT as a Tool for Assessment of Myeloablative Treatment in Patients With Acute Myeloid Leucemia(AML)', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'F18-FLT PET/CT as a Tool for Assessment of Myeloablative Treatment in Patients With AML', 'orgStudyIdInfo': {'id': '0112-12-HMO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AML', 'description': 'patients with AML prior and after treatment'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'contacts': [{'name': 'Marina Orevi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hadassah Hebrew University Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Marina Orevi, MD', 'role': 'CONTACT', 'email': 'marinaor@hadassah.org.il'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}