Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-04-15 @ 2:47 PM
Study NCT ID:
NCT00828620
Status:
TERMINATED
Last Update Posted:
2012-08-10
First Post:
2009-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Positron Emission Tomography - Computed Tomography (PET-CT) Cetuximab Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'whyStopped': 'Lack of recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-09', 'studyFirstSubmitDate': '2009-01-23', 'studyFirstSubmitQcDate': '2009-01-23', 'lastUpdatePostDateStruct': {'date': '2012-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PET response on day 7', 'timeFrame': 'day 7'}], 'secondaryOutcomes': [{'measure': 'To determine whether the PET criteria for response on day 7 correlates with the CT criteria of minimum 10% decrease in tumour size (RECIST) at week 6', 'timeFrame': 'week 6'}, {'measure': 'To define the optimal cutoff value of SUVmax and their predictive value', 'timeFrame': 'at day 7 and week 6'}, {'measure': 'To explore the test/retest reliability of PET/CT in this setting', 'timeFrame': '2 weeks'}, {'measure': 'To assess the value of PET/CT at day 7 in predicting overall survival', 'timeFrame': 'up to 1 year'}, {'measure': 'To asses the correlations between biomarkers and PET changes after Cetuximab', 'timeFrame': 'up to 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Metastatic Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'Molecular imaging with positron emission tomography (PET) using \\[18F\\] fluorodeoxyglucose (FDG) has been suggested as an early, sensitive marker of tumour response to anticancer drugs by monitoring the changes in glucose metabolism in tumours. Recently, FDG-PET has shown to be highly sensitive in detecting early response in other tumours. In this study, the investigators will prospectively investigate the role of early FDG-PET (at day 7 and week 6) in outcome prediction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'unresectable stage IV colorectal cancer pathologically proven measurable disease (RECIST) K-RAS wild type Eligible for 3rd line Irinotecan + Cetuximab Able for tolerate PET/CT imaging Serum glucose \\< 200mg/dl', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically proven colorectal cancer\n* Unresectable stage IV disease\n* K-Ras wild type tumour\n* Patients scheduled to undergo chemotherapy with irinotecan and cetuximab\n\nExclusion Criteria:\n\n* Prior abdominal/pelvic radiotherapy, surgery or chemotherapy within 3 months prior to inclusion in the study\n* Poorly controlled diabetes\n* Concomitant serious illness, such as uncontrolled angina pectoris, myocardial infarction, heart failure, uncontrolled hypertension, infection\n* Symptomatic brain metastases\n* Pregnancy or participants of reproductive potential who are sexually active and not willing/able to use medically appropriate contraception'}, 'identificationModule': {'nctId': 'NCT00828620', 'briefTitle': 'Positron Emission Tomography - Computed Tomography (PET-CT) Cetuximab Project', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Imaging for Early Response Prediction to EGF-receptor Blocking Monoclonal Antibodies in Combination Therapy for Colorectal Cancer', 'orgStudyIdInfo': {'id': 's51276 - ML5241'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PET-CT', 'description': 'Patients with Unresectable stage IV colorectal cancer; eligible for 3rd line Irinotecan and Cetuximab', 'interventionNames': ['Other: Imaging study']}], 'interventions': [{'name': 'Imaging study', 'type': 'OTHER', 'description': 'PET-CT', 'armGroupLabels': ['PET-CT']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antwerp', 'country': 'Belgium', 'facility': 'ZNA Middelheim', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Kortrijk', 'country': 'Belgium', 'facility': 'AZ Groeninge', 'geoPoint': {'lat': 50.82803, 'lon': 3.26487}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZLeuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Menen', 'country': 'Belgium', 'facility': 'H Hart Roeselare Campus menen', 'geoPoint': {'lat': 50.79722, 'lon': 3.12245}}, {'city': 'Roeselare', 'country': 'Belgium', 'facility': 'Stedelijk Ziekenhuis Roeselare', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}, {'city': 'Wilrijk', 'country': 'Belgium', 'facility': 'Sint Augustinus Ziekenhuis', 'geoPoint': {'lat': 51.16734, 'lon': 4.39513}}], 'overallOfficials': [{'name': 'Eric Van Cutsem, Prof.Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}