Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-27 @ 3:05 PM
Study NCT ID:
NCT03956459
Status:
COMPLETED
Last Update Posted:
2021-02-10
First Post:
2019-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of PET-CT Scanner Performances to Detect Infra-centimetric Lesions in Patients With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-09', 'studyFirstSubmitDate': '2019-05-16', 'studyFirstSubmitQcDate': '2019-05-17', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative rate of virtual lesions detected by each system ("Discovery MI" and "Discovery IQ")', 'timeFrame': '24 hours for each patient'}], 'secondaryOutcomes': [{'measure': 'Rate of Inter-observer concordance in radiological images interpretation', 'timeFrame': '24 hours for each patient'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FDG-PET'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'Prospective, monocentric study aiming to evaluate the PET-CT (Positron Emission Tomography - Computed Tomography) scanner performances to detect infra-centimetric lesions in two groups of patients with cancer and of different BMI (Body Mass Index) classes (BMI ≤ 25 and BMI \\> 25).\n\nFor each patient, two consecutive PET-CT scanner will be performed using the "Discovery MI" and "Discovery IQ" PET-CT scanner systems.\n\nVirtual lesions will then be created on images obtained. Images will be interpreted by two independent observers.\n\nThe study participation of each patient will be a maximum of 24 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. A patient with a cancer for which a FDG-PET (fluorodeoxyglucose-positron emission tomography) must be performed according to the standard practices\n3. OMS ≤ 1, Karnofsky Index \\> 70.\n4. Negative pregnancy test at inclusion.\n5. Patient able to maintain a lying position in a strict supine position twice.\n6. Patient affiliated to a Social Health Insurance in France.\n7. Patient who has signed informed consent prior inclusion in the study and before any specific procedures for the study.\n\nExclusion Criteria:\n\n1. Patient with unbalanced diabetic\n2. Patient with a formal contraindication usual for certain imaging procedures (severe claustrophobia, wearing a heart valve, pacemaker, etc.)\n3. Pregnant or breastfeeding woman\n4. Any psychological, family, geographical or sociological condition that does not allow medical follow-up and/or procedures provided for in the study protocol to be respected\n5. Patient protected by law'}, 'identificationModule': {'nctId': 'NCT03956459', 'acronym': 'IQversusMI', 'briefTitle': 'Evaluation of PET-CT Scanner Performances to Detect Infra-centimetric Lesions in Patients With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Institut Claudius Regaud'}, 'officialTitle': 'Evaluation of PET-CT Scanner Performances to Detect Infra-centimetric Lesions in Patients With Cancer', 'orgStudyIdInfo': {'id': '19 GENE 03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patients with a cancer', 'interventionNames': ['Other: Patients with a cancer for which a FDG-PET scanner must be performed']}], 'interventions': [{'name': 'Patients with a cancer for which a FDG-PET scanner must be performed', 'type': 'OTHER', 'description': 'For each patient, 2 consecutive PET-CT scanners will be performed using 2 different systems of PET-CT scanners:\n\n* "Discovery MI"\n* "Discovery IQ"\n\nOnly one contrast agent injection (FDG) will be given for both scanners.', 'armGroupLabels': ['Patients with a cancer']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'country': 'France', 'facility': 'Institut Universitaire du Cancer Toulouse - Oncopole', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Claudius Regaud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}