Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-25 @ 8:39 PM
Study NCT ID:
NCT01278069
Status:
COMPLETED
Last Update Posted:
2013-09-18
First Post:
2011-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PET-CT in AML for Detection of Extramedullary AML Manifestations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D023981', 'term': 'Sarcoma, Myeloid'}], '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'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-16', 'studyFirstSubmitDate': '2011-01-14', 'studyFirstSubmitQcDate': '2011-01-14', 'lastUpdatePostDateStruct': {'date': '2013-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute myeloid Leukemia', 'Myeloid Sarcoma', 'Extramedullary Acute myeloid Leukemia', '18FDG-PET-CT'], 'conditions': ['Newly Diagnosed or Relapsed Acute Myeloid Leukemia']}, 'referencesModule': {'references': [{'pmid': '21685468', 'type': 'DERIVED', 'citation': 'Stolzel F, Rollig C, Radke J, Mohr B, Platzbecker U, Bornhauser M, Paulus T, Ehninger G, Zophel K, Schaich M. (1)(8)F-FDG-PET/CT for detection of extramedullary acute myeloid leukemia. Haematologica. 2011 Oct;96(10):1552-6. doi: 10.3324/haematol.2011.045047. Epub 2011 Jun 17.'}]}, 'descriptionModule': {'briefSummary': 'Myeloid Sarcoma (or granulocytic Sarcoma or Chloroma) is well defined by the WHO. However, there are currently no data about the prevalence, sites of occurence and thr prognostic value for patients with AML with this finding. Information about this condition is based on retrospective analyses since there have been no studies trying to define the role of myeloid sarcoma in AML so far. This observational trial will include adult patients with newly diagnosed and relapsed AML in order to perform 18FDG-PET-CT imaging prior to induction chemotherapy. Furthermore, a second 18FDG-PET-CT will be performed after induction chemotherapy to define the responsiveness of these tumors to chemotherapy. The primary endpoint of this study is the prevalence of 18FDG-PET-CT positive extramedullary AML manifestations (myeloid sarcoma) in patients with newly diagnosed or relapsed AML.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Inpatients or Outpatients with newly diagnosed or relapsed AML AML', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with newly diagnosed or relapsed AML\n* AML FAB M0-2, M4-7\n* Signed informed consent after patient information\n* Male and female patients with AML age 18-80\n* 18FDG-PET-CT is available within a period of 5 days after diagnosis of AML\n\nExclusion Criteria:\n\n* AML FAB M3 (Promyelocytic Leukemia)\n* lacking willingness to cooperate\n* pregnancy or insufficient contraception\n* 18FDG-PET-CT is not available within a period of 5 days after diagnosis of AML\n* Medical condition of the patients requires an immediated start of chemotherapy'}, 'identificationModule': {'nctId': 'NCT01278069', 'acronym': 'PETAML', 'briefTitle': 'PET-CT in AML for Detection of Extramedullary AML Manifestations', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'PET-AML - Value of 18FDG-PET-CT in Patients With AML for Detection of Extramedullary AML Manifestations', 'orgStudyIdInfo': {'id': 'TUD-PETAML-043'}}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Medizinische Klinik und Poliklinik I, Universitätsklinikum Carl Gustav Carus', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PET-AML - Value of 18FDG-PET-CT in Patients With AML for Detection of Extramedullary AML Manifestations', 'investigatorFullName': 'Friedrich Stölzel, M.D.', 'investigatorAffiliation': 'Technische Universität Dresden'}}}}