Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-01-27 @ 4:45 AM
Study NCT ID:
NCT03613259
Status:
WITHDRAWN
Last Update Posted:
2020-06-09
First Post:
2018-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluorothymidine F-18 PET in Diagnosing Patients With Intermediate or High Grade Soft Tissue Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C002854', 'term': 'alovudine'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Funding expired', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-04', 'studyFirstSubmitDate': '2018-01-23', 'studyFirstSubmitQcDate': '2018-07-27', 'lastUpdatePostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Fluorothymidine F-18 mean standardized uptake value (SUV) as response to therapy.', 'timeFrame': 'Pre (=< 21 days before radiation) and Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography', 'description': 'Measured by mean SUV where the response to therapy is Pathological Response Disease change in volume of tumor (in cm3) utilizing Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) with magnetic resonance imaging (MRI). Mean, median, standard deviation, and range will be reported for continuous variables. Box plot, histogram plot, and density plot may be used to graphically show the distribution of the continuous endpoints.'}], 'secondaryOutcomes': [{'measure': 'Change in Fluorothymidine F-18 peak SUV as response to therapy', 'timeFrame': 'Pre (=< 21 days before radiation) and Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography', 'description': 'Measured by peak SUV value where the response to therapy is Pathological Response Disease change in volume of tumor (in cm3) utilizing Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) with magnetic resonance imaging (MRI). Mean, median, standard deviation, and range will be reported for continuous variables. Box plot, histogram plot, and density plot may be used to graphically show the distribution of the continuous endpoints.'}, {'measure': 'Fluorothymidine F-18 mean SUV correlation with pathology mitotic index', 'timeFrame': 'Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography', 'description': "Measured as Ki-67. Will assess the mitotic index of resection tissue. Spearman's correlation coefficient will be computed to assess the association between the mitotic index and fluorothymidine F-18 uptake parameters in post-radiation scans."}, {'measure': 'Fluorothymidine F-18 peak SUV correlation with pathology mitotic index', 'timeFrame': 'Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography', 'description': "Measured as Ki-67. Will assess the mitotic index of resection tissue. Spearman's correlation coefficient will be computed to assess the association between the mitotic index and fluorothymidine F-18 uptake parameters in post-radiation scans."}, {'measure': 'Fluorothymidine F-18 peak SUV correlation with enhancement by MRI', 'timeFrame': 'Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography', 'description': 'Measured as Ki-67. Evaluated by the standard of care magnetic resonance imaging. Will assess the size and location of irregularly increased T2-weighted signal intensity. Descriptive statistical analysis will be conducted'}, {'measure': 'Volume of T2 enhanced MRI', 'timeFrame': 'Pre (=< 21 days before radiation) and Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography', 'description': 'Measured in (cm3).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stage II Adult Soft Tissue Sarcoma', 'Stage IIA Adult Soft Tissue Sarcoma', 'Stage IIB Adult Soft Tissue Sarcoma', 'Stage IIC Adult Soft Tissue Sarcoma', 'Stage III Adult Soft Tissue Sarcoma', 'Stage IV Adult Soft Tissue Sarcoma']}, 'descriptionModule': {'briefSummary': "This pilot early phase I trial studies how well fluorothymidine F-18 positron emission tomography (PET) works in imaging patients with intermediate or high grade soft tissue sarcoma. Fluorothymidine F-18 PET may provide useful information about the tumor's response to treatment and may give the doctors early results that would better help to plan the post-surgical therapy.", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine fluorothymidine F-18 (¹⁸F-FLT) uptake parameters before and after radiotherapy.\n\nSECONDARY OBJECTIVES:\n\nI. To correlate ¹⁸F-FLT uptake post-radiotherapy scan with pathologic response. II. To correlate levels the mitotic index in surgical specimens with the ¹⁸F-FLT uptake in post-radiation scans.\n\nIII. To correlate ¹⁸F-FLT uptake both pre- and post-radiotherapy with magnetic resonance imaging (MRI) enhancement both within and around the tumor.\n\nTERTIARY OBJECTIVES:\n\nI. To compare ¹⁸F-FLT uptake and fludeoxyglucose F-18 (FDG) uptake when FDG-PET-computed tomography (CT) is available, pre-radiation, post-radiation, or both.\n\nII. To compare ¹⁸F-FLT uptake in post-radiation scans with local recurrences looking for spatial correlation.\n\nOUTLINE:\n\nPatients receive fluorothymidine F-18 intravenously (IV) over 1 minute and undergo PET scan over 60 minutes 21 or less days prior to standard of care radiation therapy and 14 or less days prior to the standard of care surgery.\n\nAfter completion of study, patients are followed up for 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must have histological evidence of an intermediate or high grade soft tissue sarcoma (STS) of any stage\n* Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as \\>= 1 cm with CT scan or MRI\n* Prior resection is allowed if there is measurable gross disease and the subject plans to have neoadjuvant radiotherapy followed by resection\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\< 4, Karnofsky performance status \\>= 40%\n* Creatinine =\\< 3 x upper limit of normal (ULM)\n* Blood urea nitrogen (BUN) =\\< 3 x ULN\n* Participants should be willing and able to have both PET-CT scans\n* Participants should be eligible for and plan to undergo neoadjuvant radiation therapy and should be seen by a radiation oncologist prior to beginning the study; radiation at an outside facility will be allowed\n* Participants should be eligible for and plan to have resection with a surgeon specializing in STS at Oregon Health and Science University (OHSU) and should be seen by said surgeon prior to beginning the study\n* Participants should have a life expectancy that is greater than the study duration\n* Participants should be willing to use adequate contraception from the time of the first PET-CT scan to 2 months after radiotherapy finishes; should a woman become pregnant while participating in this study, she should inform her treating physician immediately\n* Women with childbearing potential must have a negative pregnancy test before each PET-CT scan\n* Participants should have the ability to understand and the willingness to sign a written informed consent document\n* Participants must sign a study specific consent form prior to registration\n\nExclusion Criteria:\n\n* Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or significant inflammation at treatment site or psychiatric illness/social situations that would limit compliance with study requirements or whose lab values do not meet the criteria above are excluded\n* Pregnant women are excluded from this study\n* Breast feeding women are excluded from this study\n* Patients receiving chemotherapy during the course of radiation are excluded\n* Patients whose weights exceed the tolerance of the table are excluded; the weight limit at OHSU is 450 pounds (lbs)'}, 'identificationModule': {'nctId': 'NCT03613259', 'briefTitle': 'Fluorothymidine F-18 PET in Diagnosing Patients With Intermediate or High Grade Soft Tissue Sarcoma', 'organization': {'class': 'OTHER', 'fullName': 'OHSU Knight Cancer Institute'}, 'officialTitle': 'A Pilot Study Investigating ¹⁸F-FLT-PET as a Marker of Response to Preoperative Radiotherapy in Soft Tissue Sarcoma', 'orgStudyIdInfo': {'id': 'STUDY00016373'}, 'secondaryIdInfos': [{'id': 'NCI-2017-00833', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'SOL-16169-LX'}, {'id': 'STUDY00016373', 'type': 'OTHER', 'domain': 'OHSU Knight Cancer Institute'}, {'id': 'P01CA042045', 'link': 'https://reporter.nih.gov/quickSearch/P01CA042045', 'type': 'NIH'}, {'id': 'P30CA069533', 'link': 'https://reporter.nih.gov/quickSearch/P30CA069533', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (fluorothymidine F-18 PET)', 'description': 'Patients receive fluorothymidine F-18 IV over 1 minute and undergo PET scan over 60 minutes 21 or less days prior to standard of care radiation therapy and 14 or less days prior to the standard of care surgery.', 'interventionNames': ['Drug: Fluorothymidine F-18', 'Other: Laboratory Biomarker Analysis', 'Procedure: Positron Emission Tomography']}], 'interventions': [{'name': 'Fluorothymidine F-18', 'type': 'DRUG', 'otherNames': ['¹⁸F-FLT', "3'-deoxy-3'-(¹⁸F) fluorothymidine", "3'-deoxy-3'-[¹⁸F]fluorothymidine", 'fluorothymidine F 18'], 'description': 'Given IV', 'armGroupLabels': ['Diagnostic (fluorothymidine F-18 PET)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Diagnostic (fluorothymidine F-18 PET)']}, {'name': 'Positron Emission Tomography', 'type': 'PROCEDURE', 'otherNames': ['Medical Imaging, Positron Emission Tomography', 'PET', 'PET Scan', 'positron emission tomography scan', 'Positron-Emission Tomography', 'proton magnetic resonance spectroscopic imaging'], 'description': 'Undergo fluorothymidine F-18 PET', 'armGroupLabels': ['Diagnostic (fluorothymidine F-18 PET)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Arthur Y Hung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OHSU Knight Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OHSU Knight Cancer Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Arthur Hung', 'investigatorAffiliation': 'OHSU Knight Cancer Institute'}}}}