Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-01 @ 11:28 AM
Study NCT ID:
NCT01821105
Status:
COMPLETED
Last Update Posted:
2016-03-02
First Post:
2012-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
2 Phase Comparison of Pre-operative CT and PET Images for Metastatic Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D019788', 'term': 'Fluorodeoxyglucose F18'}, {'id': 'D003936', 'term': 'Diagnosis, Computer-Assisted'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Edward.Martin@osumc.edu', 'phone': '614-293-8843', 'title': 'Edward Martin, MD', 'organization': 'The Ohio State University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.', 'eventGroups': [{'id': 'EG000', 'title': 'Preoperative PET and CT Scans', 'description': 'Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.\n\nPET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).\n\nCT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.\n\nfludeoxyglucose F 18: Given IV\n\ncomputer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery', 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Detection of Position Accuracy With Handheld Probe on Anatomical Location.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Preoperative PET and CT Scans', 'description': 'Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.\n\nPET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).\n\nCT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.\n\nfludeoxyglucose F 18: Given IV\n\ncomputer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery'}], 'classes': [{'title': 'true postive', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'false positive', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'not evaluable', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 12 months', 'unitOfMeasure': 'lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'number of tumor lesions detected by the probe'}, {'type': 'SECONDARY', 'title': 'All Adverse Events and Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Preoperative PET and CT Scans', 'description': 'Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.\n\nPET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).\n\nCT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.\n\nfludeoxyglucose F 18: Given IV\n\ncomputer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 12 months', 'unitOfMeasure': 'patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tumor Detection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Preoperative PET and CT Scans', 'description': 'Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.\n\nPET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).\n\nCT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.\n\nfludeoxyglucose F 18: Given IV\n\ncomputer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At surgery', 'unitOfMeasure': 'lesions detected', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Preoperative PET and CT Scans', 'description': 'Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.\n\nPET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).\n\nCT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.\n\nfludeoxyglucose F 18: Given IV\n\ncomputer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Preoperative PET and CT Scans', 'description': 'Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.\n\nPET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).\n\nCT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.\n\nfludeoxyglucose F 18: Given IV\n\ncomputer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000', 'lowerLimit': '31', 'upperLimit': '78'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Mean time interval from initial treatment to PET scan', 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '102'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'FULL_RANGE'}, {'title': 'Mean time interval from PET scan to surgery/GP study', 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '41'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-03', 'studyFirstSubmitDate': '2012-08-09', 'resultsFirstSubmitDate': '2015-11-23', 'studyFirstSubmitQcDate': '2013-03-26', 'lastUpdatePostDateStruct': {'date': '2016-03-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-12-29', 'studyFirstPostDateStruct': {'date': '2013-03-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of Position Accuracy With Handheld Probe on Anatomical Location.', 'timeFrame': 'up to 12 months'}], 'secondaryOutcomes': [{'measure': 'All Adverse Events and Complications', 'timeFrame': 'up to 12 months'}, {'measure': 'Tumor Detection', 'timeFrame': 'At surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['computed tomography', 'CT scan', 'positron emission tomography', 'PET', 'Metastatic Colorectal Cancer'], 'conditions': ['Recurrent Colon Cancer', 'Recurrent Rectal Cancer', 'Stage IV A Bladder Cancer', 'Stage IV A Rectal Cancer', 'Stage IV B Colon Cancer', 'Stage IV B Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '17634125', 'type': 'RESULT', 'citation': 'Sarikaya I, Povoski SP, Al-Saif OH, Kocak E, Bloomston M, Marsh S, Cao Z, Murrey DA, Zhang J, Hall NC, Knopp MV, Martin EW Jr. Combined use of preoperative 18F FDG-PET imaging and intraoperative gamma probe detection for accurate assessment of tumor recurrence in patients with colorectal cancer. World J Surg Oncol. 2007 Jul 16;5:80. doi: 10.1186/1477-7819-5-80.'}], 'seeAlsoLinks': [{'url': 'http://cancer.osu.edu', 'label': 'Jamesline'}]}, 'descriptionModule': {'briefSummary': 'This pilot phase II studies how well computed tomography (CT) and positron emission tomography (PET) imaging works in detecting disease in patients undergoing surgery for metastatic colorectal cancer. Diagnostic procedures, such as CT and PET scans, done before and during surgery may help find colorectal cancer and help guide surgery', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the feasibility of rigidly (linearly) registering PET to CT images and applying this fused dataset to guide surgery with an image-guided navigation system and a handheld positron probe in order to facilitate disease detection and improve resection accuracy in advanced stage colorectal cancer.\n\nII. To complete development of software for the nonlinear registration of PET and CT datasets.\n\nOUTLINE:\n\nPatients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive 18 F fludeoxyglucose (FDG) intravenously (IV) 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histologically-confirmed colorectal carcinoma and preoperative PET scan with evidence of hypermetabolic lesions suspicious for cancer will be eligible for this study. In cases of primary cancer, there must be a tissue-confirmed diagnosis. In recurrent cases, patients must have clinical evidence by CT or MRI of disease suitable for resection.\n* Patients must be candidates for clinically indicated surgery.\n* Patients with recurrent disease may have had prior surgery and/or chemotherapy with no limit to the number of prior therapeutic procedures or chemotherapeutic regimens.\n* Patients must have a performance status of 0, 1 or 2 by ECOG(Eastern Cooperative Oncology Group)standards.\n* Patients must give written informed consent including consent to have IV line placed for FDG administration.\n* Patients must be at least 18 years of age. Children under the age of 18 are excluded from the study due to the rarity of colorectal cancer in children.\n* Because radiolabeled agents are known to be teratogenic, women of child-bearing potential and men must agree to use an acceptable form of contraception prior to study entry and for the duration of the study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n* Organ function requirements: Patients must have organ and marrow function adequate to undergo laparotomy. Specifically:\n* Serum creatinine \\< 2.0 mg/dl\n* Serum bilirubin \\< 2.0 mg/dl\n* AST(aspartate aminotransferase,serum glutamate oxaloacetate transaminase, serum glutamate oxaloacetate transaminase,serum glutamate pyruvate transaminase)\\[SGOT\\]/ALT\\[SGPT\\]\\<4 times institutional upper limit of normal\n* Total WBC(white blood cell)\\>4,000/mm3 or ANC(absolute neutrophil count)\\> 1,500/mm3\n* Platelets \\> 100,000/mm3\n* Hgb \\>10g/dl\n* Patient must have no clinically significant cardiac disease (New York Heart Association Class III/IV); no serious infection requiring treatment with antibiotics; no other serious ill-ness or illness requiring the use of steroids; no clinically significant pulmonary disease or other illness that would contraindicate or increase the risk of complications at surgery.\n* Fasting blood sugar less than 120 mg/dl\n\nExclusion Criteria:\n\n* Patients with active CNS (central nervous system)tumor involvement are ineligible.\n* Any patient who has retained childbearing potential will not be pregnant or lactating and must use adequate contraception to assure avoidance of conception.\n* Body size prohibits use of the diagnostic equipment (portable CT scanner).\n* Tumor burden is so great (as determined by preoperative PET scanning or intraoperative findings) that further surgery is not advised.\n* If lesions are detected with preoperative CT but not with PET scanning (in other words, all patients will have a positive PET scan as part of the inclusion criteria).'}, 'identificationModule': {'nctId': 'NCT01821105', 'briefTitle': '2 Phase Comparison of Pre-operative CT and PET Images for Metastatic Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'A 2 Phase Comparison of Pre-operative CT AND PET Images in the Intraoperative Detection of Disease to a Hand-held Probe, and to an Intraoperative CT Scan in Patients Undergoing Surgery for Metastatic Colorectal Cancer.', 'orgStudyIdInfo': {'id': 'OSU-0375'}, 'secondaryIdInfos': [{'id': 'NCI-2012-01242', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preoperative PET and CT Scans', 'description': 'Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.', 'interventionNames': ['Procedure: PET Scan', 'Procedure: CT Scan', 'Radiation: fludeoxyglucose F 18', 'Procedure: computer-aided detection/diagnosis']}], 'interventions': [{'name': 'PET Scan', 'type': 'PROCEDURE', 'description': 'All patients will receive whole body PET scans (chest-abdomen-pelvis).', 'armGroupLabels': ['Preoperative PET and CT Scans']}, {'name': 'CT Scan', 'type': 'PROCEDURE', 'description': 'All patients will receive CT scans of the abdomen and pelvis with contrast.', 'armGroupLabels': ['Preoperative PET and CT Scans']}, {'name': 'fludeoxyglucose F 18', 'type': 'RADIATION', 'otherNames': ['18FDG', 'FDG'], 'description': 'Given IV', 'armGroupLabels': ['Preoperative PET and CT Scans']}, {'name': 'computer-aided detection/diagnosis', 'type': 'PROCEDURE', 'description': 'Undergo computer-aided detection/diagnosis during surgery', 'armGroupLabels': ['Preoperative PET and CT Scans']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Edward Martin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Edward Martin', 'investigatorAffiliation': 'Ohio State University Comprehensive Cancer Center'}}}}