Ignite Creation Date:
2025-12-26 @ 11:47 AM
Ignite Modification Date:
2025-12-26 @ 11:47 AM
Study NCT ID:
NCT00396916
Status:
COMPLETED
Last Update Posted:
2007-04-11
First Post:
2006-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hybrid PET/CT in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'lastUpdateSubmitDate': '2007-04-10', 'studyFirstSubmitDate': '2006-11-07', 'studyFirstSubmitQcDate': '2006-11-07', 'lastUpdatePostDateStruct': {'date': '2007-04-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the impact of the imaging modality on patient management'}], 'secondaryOutcomes': [{'measure': 'the impact of the imaging modality on patient management'}]}, 'conditionsModule': {'keywords': ['cancer patients'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of the present study is to assess the role of hybrid PET/CT imaging diagnosis of active malignancy in cancer patients with rising tumor markers after treatment and in the diagnosis of primary tumor in patients with metastatic cancer of unknown origin. The clinical impact of PET/CT in the management and treatment of these two groups of cancer patients will be evaluated'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cancer patients in complete remission after treatment, with serial elevation of serum tumor markers and negative CT or other conventional imaging test.\n* Patients with newly diagnosed metastatic cancer with unknown primary tumor\n* Glucose levels below 150-200\n* Patient signed informed consent\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Patient unable or not willing to tolerate the test until its completion\n* One or more of the inclusion criteria is not fulfilled'}, 'identificationModule': {'nctId': 'NCT00396916', 'briefTitle': 'Hybrid PET/CT in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'The Value of Novel Imaging Modality, Hybrid PET/CT, Using F18-Flurodeoxyglucose(FDG) in the Assessment of Cancer Patients. Impact of PET/CT on Clinical Management of Patients With Rising Tumor Markers and no Other Evidence of Disease and in Patients With Metastatic Cancer of Unknown Origin', 'orgStudyIdInfo': {'id': 'hybridCTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PET/CT imaging', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Rachel Bar-Shalom, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rambam Health Care Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}}}}