Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-04 @ 4:40 AM
Study NCT ID:
NCT00335751
Status:
COMPLETED
Last Update Posted:
2020-07-31
First Post:
2006-06-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PET Scan Combined With CT Scan in Evaluating Treatment Response in Patients Undergoing Treatment for Bone Cancer or Soft Tissue Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D012516', 'term': 'Osteosarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018213', 'term': 'Neoplasms, Bone Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-29', 'studyFirstSubmitDate': '2006-06-08', 'studyFirstSubmitQcDate': '2006-06-08', 'lastUpdatePostDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-06-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine whether device that combines fludeoxyglucose ^18F positron-emission tomography (FDG-PET) and CT scanning (FDG-PET/CT) can accurately locate and determine disease in patients who are undergoing treatment for bone or soft tissue sarcoma.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': '•Determine whether FDG-PET/CT scanning is effective in evaluating the response of sarcoma to treatment.', 'timeFrame': '6 months'}, {'measure': '•Determine whether the new FDG-PET/CT device improves the ability to evaluate treatment response early and accurately.', 'timeFrame': '6 months'}, {'measure': '•Correlate changes in glucose metabolic activity early and late after treatment with overall and progression-free survival.', 'timeFrame': '6 months'}, {'measure': '•Correlate changes in glucose metabolic activity early and late after treatment with degree of tumor necrosis at the time of surgery.', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['recurrent adult soft tissue sarcoma', 'stage I adult soft tissue sarcoma', 'localized osteosarcoma', 'metastatic osteosarcoma', 'recurrent osteosarcoma', 'stage II adult soft tissue sarcoma', 'stage III adult soft tissue sarcoma', 'stage IV adult soft tissue sarcoma'], 'conditions': ['Sarcoma']}, 'descriptionModule': {'briefSummary': "RATIONALE: Diagnostic procedures, such as PET scan and CT scan, may help doctors determine the extent of cancer and predict a patient's response to treatment and help plan the best treatment.\n\nPURPOSE: This clinical trial is studying how well PET scan combined with CT scan evaluates treatment response in patients undergoing treatment for bone cancer or soft tissue sarcoma.", 'detailedDescription': 'OBJECTIVES:\n\n* Determine whether an FDA-approved device that combines fludeoxyglucose \\^18F positron-emission tomography (FDG-PET) and CT scanning (FDG-PET/CT) can accurately locate and determine the extent of disease in patients who are undergoing treatment for bone or soft tissue sarcoma.\n* Determine whether FDG-PET/CT scanning is effective in evaluating the response of sarcoma to treatment.\n* Determine whether the new FDG-PET/CT device improves the ability to evaluate treatment response early and accurately.\n* Correlate changes in glucose metabolic activity early and late after treatment with overall and progression-free survival.\n* Correlate changes in glucose metabolic activity early and late after treatment with degree of tumor necrosis at the time of surgery.\n\nOUTLINE: This is a prospective, pilot study. Patients are stratified according to disease (high-grade soft tissue sarcoma vs low-grade soft tissue sarcoma vs osteosarcoma).\n\nPatients undergo fludeoxyglucose \\^18F positron-emission tomography (FDG-PET)/CT scanning at baseline and then within 2 weeks and 12 weeks after the start of treatment (total of 3 scans).\n\nPROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed bone or soft tissue sarcoma\n* Scheduled to undergo treatment (i.e., chemotherapy and/or radiotherapy) for sarcoma\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* Not claustrophobic\n* Able to lie supine for 1 hour\n* Patients with diabetes mellitus allowed provided serum glucose levels ≤ 200 mg/dL\n\nExclusion Criteria:\n\n* pregnant\n* other malignancies within the past 5 years (except completely resected cervical or nonmelanoma skin cancer) unless the malignancy was curatively treated and is at low risk for recurrence'}, 'identificationModule': {'nctId': 'NCT00335751', 'briefTitle': 'PET Scan Combined With CT Scan in Evaluating Treatment Response in Patients Undergoing Treatment for Bone Cancer or Soft Tissue Sarcoma', 'organization': {'class': 'OTHER', 'fullName': 'Jonsson Comprehensive Cancer Center'}, 'officialTitle': 'Glucose Metabolic Response by PET/CT to Sarcoma Treatments', 'orgStudyIdInfo': {'id': 'CDR0000480348'}, 'secondaryIdInfos': [{'id': 'UCLA-0508095-01'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'positron emission tomography computed tomography (PET/CT)', 'description': 'The first PET/CT scan will be performed as part of clinical evaluation of sarcoma; The second PET/CT scan will be performed 6 weeks after the start of chemotherapy treatment OR 6 weeks after the end of radiation therapy, to monitor response of sarcoma to treatment.', 'interventionNames': ['Procedure: positron emission tomography computed tomography (PET/CT)']}], 'interventions': [{'name': 'positron emission tomography computed tomography (PET/CT)', 'type': 'PROCEDURE', 'description': 'The first PET/CT scan will be performed as part of clinical evaluation of sarcoma; The second PET/CT scan will be performed 6 weeks after the start of chemotherapy treatment OR 6 weeks after the end of radiation therapy, to monitor response of sarcoma to treatment.', 'armGroupLabels': ['positron emission tomography computed tomography (PET/CT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-1781', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center at UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Johannes Czernin, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Jonsson Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}