Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2026-02-09 @ 8:58 AM
Study NCT ID:
NCT01594203
Status:
UNKNOWN
Last Update Posted:
2012-05-08
First Post:
2012-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contribution of F18-FDG PET/CT to the Early Assessment of Pazopanib Therapy Efficacy in Advanced Soft Tissue Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2013-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-07', 'studyFirstSubmitDate': '2012-04-30', 'studyFirstSubmitQcDate': '2012-05-07', 'lastUpdatePostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure of extent and intensity (standardized uptake value - SUV) of disease demonstrated on PET/CT images before and after treatment.', 'timeFrame': '1 week'}, {'measure': 'determination of treatment efficiency by comparison of PET data (SUV) with CT changes (cm)in 3 studies and clinical information.', 'timeFrame': '4 week'}], 'secondaryOutcomes': [{'measure': 'prediction of treatment efficiency', 'timeFrame': '6 weeks'}]}, 'conditionsModule': {'keywords': ['Soft Tissue Sarcoma', 'Pazopanib', 'F18-FDG PET/CT'], 'conditions': ['Soft Tissue Sarcoma (STS)']}, 'descriptionModule': {'briefSummary': 'Soft Tissue Sarcoma (STS) is a rare tumor but can grow in different areas, for example, in 60% in limbs and about 20 % in retroperitoneum; and frequently is inoperable. Despite novel therapy in advanced cases survival is still short, approximately 12 month.\n\nPazopanib oral angiogenesis inhibitor was recently shown as promising drug for advanced pretreated STS.\n\nFunctional imaging especially F18-FDG PET/CT is a good modality for FDG avid tumor either for pre- / post- treatment evaluation or follow up.\n\nEarly detection of treatment response to therapy by whole body FDG PET/CT allows for change of treatment as early as possible,when the tumor is non-responsive before serious side effects appear or before depletion of body resources.\n\nThe aim of the study is to investigate the contribution of FDG PET/CT to assessment of treatment response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with advanced Soft Tissue Sarcoma prior to pazopanib therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with advanced Soft Tissue Sarcoma prior to pazopanib treatment\n\nExclusion Criteria:\n\n* Other treatment\n* FDG negative tumor'}, 'identificationModule': {'nctId': 'NCT01594203', 'briefTitle': 'Contribution of F18-FDG PET/CT to the Early Assessment of Pazopanib Therapy Efficacy in Advanced Soft Tissue Sarcoma', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'orgStudyIdInfo': {'id': '0103-12-HMO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Advanced Soft Tissue Sarcoma', 'description': 'patients with advanced Soft Tissue Sarcoma', 'interventionNames': ['Other: F18-FGD PET/CT']}], 'interventions': [{'name': 'F18-FGD PET/CT', 'type': 'OTHER', 'armGroupLabels': ['Advanced Soft Tissue Sarcoma']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'contacts': [{'name': 'Marina Orevi, MD', 'role': 'CONTACT', 'email': 'marinaor@hadassah.org.il'}, {'name': 'Daniela Katz, MD', 'role': 'CONTACT', 'email': 'DanielaKatz@hadassah.org.il'}], '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'}, {'name': 'Daniela Katz, MD', 'role': 'CONTACT', 'email': 'DanielaKatz@hadassah.org.il'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}