Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-01-26 @ 4:16 PM
Study NCT ID:
NCT02317393
Status:
COMPLETED
Last Update Posted:
2020-07-09
First Post:
2014-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contribution of the Imaging to the Expression of intégrines αvβ3 for the Characterization of Residual Masses of Non-seminoma Tumors at the End of Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537844', 'term': 'Nonseminomatous germ cell tumor'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-08', 'studyFirstSubmitDate': '2014-08-25', 'studyFirstSubmitQcDate': '2014-12-15', 'lastUpdatePostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of teratoma', 'timeFrame': 'up to 6 weeks', 'description': 'Efficacity to differentiate mature teratoma and necroses within the residual masses of germinal non-seminoma tumors.'}], 'secondaryOutcomes': [{'measure': 'Metabolic profile', 'timeFrame': 'up to 10 weeks', 'description': 'Number of patients having at least a tumor detected by TEP K5-RGD requiring a surgery, divided by the number of patients having actually at least a tumor (by anatomopathologie) requiring a chirurgie'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nuclear medicine', 'Positron emission tomography', 'avb3 integrin expression'], 'conditions': ['Non-seminomatous Germ Cell Tumors', 'Metastasis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the contribution of the imaging to the expression of intégrines αvβ3 for the characterization of the residual masses of non-seminoma tumors at the end of chemotherapy.\n\nThe investigators hope that the results of this first stage of the clinical trial come to consolidate the preclinical results obtained by the investigators team to characterizing the interest and the strong contribution of the use of a tracer resting on the expression of αvβ3 integrine for the diagnosis of simple necrosed mass at the end of the treatment of a non-seminoma tumor, so allowing to defer a surgery to about 40 % of the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Man or woman aged 18 years or more\n* Patients with one or several ganglionic or visceral residual masses (\\> to 1 cm) after chemotherapy for metastatic non-seminoma testicular tumor, and for which or which a surgery is planned;\n* Affiliate to a social security system;\n* Signed written Informed consent\n\nExclusion Criteria:\n\n* Patient deprived of liberty as a result of a justice or administrative decision\n* Any medical or psychological condition which could compromise the capacity of the patient to participate in the study;\n* Previous or concomitant other cancer in 5 years except basal cell carcinomas'}, 'identificationModule': {'nctId': 'NCT02317393', 'acronym': 'TERMATEP', 'briefTitle': 'Contribution of the Imaging to the Expression of intégrines αvβ3 for the Characterization of Residual Masses of Non-seminoma Tumors at the End of Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Francois Baclesse'}, 'officialTitle': 'A Prospective,Multicenter, Phase II Study to Evaluate the Contribution of the Imaging TEP to the Expression of intégrines αvβ3 for the Characterization of the Residual Masses of Non-seminoma Tumors at the End of Chemotherapy', 'orgStudyIdInfo': {'id': 'TERMATEP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'K5-RGD PET + FDG', 'description': 'Both PET examinations will be performed within 4-6 weeks after the end of chemotherapy, with a maximal delay from end of chemotherapy of 2 months. Delay between FDG and 18F-K5-RGD PET scans will not exceed 2 weeks.', 'interventionNames': ['Other: K5-RGD PET', 'Other: FDG']}], 'interventions': [{'name': 'K5-RGD PET', 'type': 'OTHER', 'description': 'Both PET examinations will be performed within 4-6 weeks after the end of chemotherapy', 'armGroupLabels': ['K5-RGD PET + FDG']}, {'name': 'FDG', 'type': 'OTHER', 'description': 'Both PET examinations will be performed within 4-6 weeks after the end of chemotherapy', 'armGroupLabels': ['K5-RGD PET + FDG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '14076', 'city': 'Caen', 'country': 'France', 'facility': 'Centre François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Rouen', 'country': 'France', 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Rouen', 'country': 'France', 'facility': 'CHU Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Toulouse', 'country': 'France', 'facility': 'Institut Claudius Regaud', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Nicolas AIDE, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre François Baclesse, CAEN, France'}, {'name': 'Arnaud DOERFLER, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Côte de Nacre, CAEN, France'}, {'name': 'Pierre VERA, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Henri Becquerel, ROUEN, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Francois Baclesse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}