Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-02-20 @ 4:49 PM
Study NCT ID:
NCT02233595
Status:
TERMINATED
Last Update Posted:
2019-08-13
First Post:
2014-09-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Rectal Cancer Treatment Response Using PET/MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059248', 'term': 'Chemoradiotherapy'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Low Accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-08', 'studyFirstSubmitDate': '2014-09-03', 'studyFirstSubmitQcDate': '2014-09-05', 'lastUpdatePostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in SUVmax', 'timeFrame': '2 months', 'description': 'To determine whether percent change in SUVmax correlates with the extent of pathologic primary tumor response'}, {'measure': 'tumor volume', 'timeFrame': '2 months', 'description': 'To determine whether percent change in tumor volume correlates with the extent of pathologic primary tumor response'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MRI', 'PET', 'rectal cancer', 'adjuvant chemotherapy'], 'conditions': ['Rectal Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'The investigators will be using the combination of FDG-PET and multiparametric MRI in pre- and post-adjuvant chemoradiation therapy in order to attempt to predict pathologic response on surgical resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '20 patients with newly diagnosed rectal adenocarcinoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A diagnosis of histopathologically confirmed rectal adenocarcinoma.\n* Locally advanced disease as determined by ERUS or pelvic MRI. Endoscopy reports should clearly state both the T and N stage.\n* Patients with cT2N1-3M0 or cT2-4NxM0 will be considered eligible for participation.\n* Age ≥18.\n* Ability to understand a written informed consent document and the willingness to sign it.\n* Tumor must be determined to be surgically resectable. Surgical resection is planned to take place at Univeristy of California, San Francisco (UCSF).\n* Neoadjuvant chemoradiation prior to resection is planned..\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.\n\nExclusion Criteria:\n\n* ERUS tumor state of T1.\n* Radiographic evidence of metastatic disease\n* Weight in excess of limitations of the scanner or girth that prohibits entry into the bore of the PET/CT scanner due to size.\n* Any medical condition which impairs the ability to lie flat and without movement for 15 minutes (e.g. cough, severe arthritis, etc.)\n* Prior receipt of any therapy, including local excision, radiation or chemotherapy, for the diagnosed rectal adenocarcinoma.\n* Prior history of pelvic radiation.\n* Uncontrolled hyperglycemia (defined as inability to achieve a glucose of \\<250 mg/dL at time of fluorodeoxyglucose (FDG) injection).\n* Impaired renal function (CKD 4 or 5: estimated glomerular filtration rate (eGFR) \\< 30 mLs/min), which is a contraindication to gadolinium containing contrast.\n* Known allergy to gadolinium containing contrast agents.\n* Contraindication to use of fluoropyrimidines as a radiosensitizing agent.\n* Pregnancy or nursing. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to randomization. This is because of the potential teratogenic effects of the involved imaging modalities, radiation, and chemotherapy.'}, 'identificationModule': {'nctId': 'NCT02233595', 'acronym': 'Rectal PET/MRI', 'briefTitle': 'Evaluation of Rectal Cancer Treatment Response Using PET/MRI', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Evaluation of Rectal Cancer Treatment Response Using PET/MRI', 'orgStudyIdInfo': {'id': '144513'}, 'secondaryIdInfos': [{'id': 'NCI-2015-00980', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trials Reporting Program'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adjuvant chemotherapy', 'interventionNames': ['Radiation: Chemoradiation']}], 'interventions': [{'name': 'Chemoradiation', 'type': 'RADIATION', 'armGroupLabels': ['Adjuvant chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94107', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Imaging Center at China Basin', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Thomas Hope, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}