Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-02-25 @ 5:49 PM
Study NCT ID:
NCT04467567
Status:
COMPLETED
Last Update Posted:
2024-02-09
First Post:
2020-06-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dosimetry Using a CZT-camera Following LUTATHERA® Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-08', 'studyFirstSubmitDate': '2020-06-22', 'studyFirstSubmitQcDate': '2020-07-08', 'lastUpdatePostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Results of the dosimetry obtained from the 2 cameras', 'timeFrame': '168 hours', 'description': 'Comparison between dosimetry results obtained from the conventional camera and from the VERITON-CT™ CZT camera.'}], 'secondaryOutcomes': [{'measure': 'Results of the dosimetry obtained from the 2 cameras when utilizing 3 points of measurement and when utilizing 2 points of measurement', 'timeFrame': '24 hours, 96 hours, 168 hours', 'description': 'Measurement of the average absorbed doses to sensitive organs (bone marrow and kidneys) and to tumor lesions obtained when utilizing 3 measurement points (24h, 96h and 168h) and then obtained when utilizing 2 measurement points (24h and 168h) after the administration of Lutathera®, from both a VERITON-CT™ camera and from a SYMBIA T camera.'}, {'measure': 'Correlation between the dosimetry results', 'timeFrame': '24 hours, 96 hours, 168 hours', 'description': 'Average absorbed doses to the kidneys and to the bone marrow versus renal function (creatininaemia, glomerular filtration rate \\[GFR\\], blood ionogram), and versus bone marrow activity (blood count).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dosimetry']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the consistency between a dosimetry protocol using a large field of view CZT-camera and the dosimetry protocol used for recordings acquired with a conventional camera. Therefore, with the conventional camera, recordings are acquired on the "high energy" peak of lutetium 177 (208 keV) using a medium energy collimator. With the VERITON-CT™ CZT camera, recordings are acquired using the low energy peak of 113 keV. A second objective is to compare results between the dosimetry calculated using 3 measurement points (24h, 96h and 168h) and the dosimetry calculated using 2 measurement points (24h and 168h), obtained from the SYMBIA T conventional camera and the VERITON-CT™camera, respectively.', 'detailedDescription': '177Lu-DOTATATE has been proven to be an effective therapy for treatment of neuroendocrine tumors. Treatment with \\[177Lu\\]-DOTA-TATE consists of 4 cycles, with an infusion of 7.4 GBq (200mCi) every 8 weeks. An imaging protocol to study dosimetry throughout the cycles is essential to determine the average dose absorbed by critical organs and by tumor lesions. The critical organs studied in association with \\[177Lu\\]-octreotate treatment are predominantly kidneys and the bone marrow. In this open-label trial, 15 patients undergoing Lutathera® treatment could be enrolled in the study. Patients will have an abdominopelvic SPECT / CT recorded using a conventional Anger camera, followed by a whole-body SPECT / CT recording using a CZT camera. Recordings will be acquired at 24 hours, 96 hours and then at 7 days after the Lutathera® infusion that is administered during one of the 4 treatment cycles. The correlation between the dosimetry results and the appearance of possible grade 3 and 4 side effects will be established.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major adult subject\n* ECOG ≤ 2\n* Subject receiving treatment with Lutathera®\n* Subject having given written, free and informed consent\n* Affiliation to a social security scheme\n\nExclusion Criteria:\n\n* Contraindication to treatment with Lutathera®\n* Subject referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the public health code.\n* Pregnant woman, parturient or nursing mother.\n* Subject with a legal protection measure (guardianship, curatorship, safeguard of justice).\n* Subject unable to express consent.\n* Subject deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under Articles L. 3212-1 and L.3213-1'}, 'identificationModule': {'nctId': 'NCT04467567', 'acronym': 'EVADOVE177Lu', 'briefTitle': 'Dosimetry Using a CZT-camera Following LUTATHERA® Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Optimization for Clinical Routine of a Dosimetry Protocol Using the Large Field of View VERITON-CT CZT Camera in Patients Treated With LUTATHERA® [177Lu- [DOTA0, Tyr3] -Octreotate', 'orgStudyIdInfo': {'id': '2020-A20200-620'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients treated with lutathera', 'description': 'Patients undergoing treatment with Lutathera® and who accept to participate in the study, regardless of the cycle of treatment, 1, 2, 3 or 4.', 'interventionNames': ['Other: Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)']}], 'interventions': [{'name': 'Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)', 'type': 'OTHER', 'description': 'SPECT/CT will be performed after Lutathera® treatment (at 24h, 96h and 168h after the infusion of Lutathera®) on the conventional camera and on the VERITON-CT camera', 'armGroupLabels': ['patients treated with lutathera']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Chru Nancy', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Elodie CHEVALIER', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}