Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT04272658
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2020-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PET/CT Whole-body Dynamic Acquisition at FDG to Metastatic Melanoma Under Immunotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2026-06-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-25', 'studyFirstSubmitDate': '2020-01-20', 'studyFirstSubmitQcDate': '2020-02-14', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Values of the Ki absorption coefficient resulting from a FDG PET / CT full-body 4D dynamic acquisition to differentiate the pseudo-progression / progression of metastatic melanoma treated with ICI', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Correlation between the Ki lesion values derived from PET1 and the quantitative parameters resulting from PET0 histological specifications of the tumors (% PD-L1, T-CD8 infiltration, PTEN status) to differentiate pseudo-progression / progression.', 'timeFrame': '5 years'}, {'measure': 'Correlation between the Ki lesional values resulting from the 4D acquisition of the PET / CT from PET1 and PET0 the biological parameters (LDH, leucocytes, neutrophils) to differentiate pseudo-progression / progression', 'timeFrame': '5 years'}, {'measure': 'Correlation between the Ki lesion values resulting from the 4D acquisition of FDG PET / CT for PET1 and the quantitative parameters resulting from PET0 to differentiate pseudo-progression / progression', 'timeFrame': '5 years'}, {'measure': 'Correlation between lesional Ki values resulting from the 4D acquisition of FDG PET / CT for from PET1 and the quantitative parameters resulting from PET0 ICI- related adverse effect to differentiate pseudo-progression / progression', 'timeFrame': '5 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Metastatic Melanoma']}, 'descriptionModule': {'briefSummary': 'The value of 4D body-to-whole dynamic acquisition in FDG PET / CT to differentiate progression / pseudo-progression during the first therapeutic assessment (PET1) of metastatic melanoma treated with immune checkpoint inhibitors (ICI)to predict the progression of the disease..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with metastatic melanoma treated with immune checkpoint inhibitors (ICI) and do 4D body-to-whole dynamic acquisition in FDG PET / CT to differentiate progression / pseudo-progression', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient old ≥ 18 years\n* With metastatic melanoma\n* Treated with anti-PD1 : Nivolumab or Pembrolizumab or Combo IPI-Nivo\n* Having formulated a non-opposition\n\nExclusion Criteria:\n\n* \\- Minor patient \\< 18 years\n* Pregnancy or breastfeeding\n* Other type of tumor than metastatic melanoma\n* Non-eligibility for the examination\n* Refusal of participation'}, 'identificationModule': {'nctId': 'NCT04272658', 'acronym': 'IMMUNOPET2', 'briefTitle': 'PET/CT Whole-body Dynamic Acquisition at FDG to Metastatic Melanoma Under Immunotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Interest in PET/CT Whole-body Dynamic Acquisition at FDG to Differentiate Progression/Pseudo Progression of Metastatic Melanoma Under Immunotherapy', 'orgStudyIdInfo': {'id': '29BRC19.0194 (IMMUNO-PET2)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'value of 4D body-to-whole dynamic acquisition in FDG', 'description': 'differentiate pseudo-progression / progression during the first therapeutic assessment by FDG PET / CT (PET1) using data from the 4D whole-body dynamic acquisition, without having to re-evaluate closely. during a PET1 \'this "unconfirmed progression" after 2 new treatment cures of immune checkpoint inhibitors in metastatic melanoma', 'interventionNames': ['Diagnostic Test: value of 4D body-to-whole dynamic acquisition in FDG']}], 'interventions': [{'name': 'value of 4D body-to-whole dynamic acquisition in FDG', 'type': 'DIAGNOSTIC_TEST', 'description': 'differentiate pseudo-progression / progression during the first therapeutic assessment by FDG PET / CT (PET1) using data from the 4D whole-body dynamic acquisition, without having to re-evaluate closely. during a PET1 \'this "unconfirmed progression" after 2 new treatment cures of ICI', 'armGroupLabels': ['value of 4D body-to-whole dynamic acquisition in FDG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29200', 'city': 'Brest', 'state': 'Finistere', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ronan ABGRAL, MD-PhD', 'role': 'CONTACT'}], 'facility': 'Hospital University ff Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}], 'centralContacts': [{'name': 'Ronan ABGRAL, MD-PhD', 'role': 'CONTACT', 'email': 'ronan.abgral@chu-brest.fr', 'phone': '+33 (0) 298223327'}, {'name': 'Karim AMRANE, MD', 'role': 'CONTACT', 'email': 'amranekarim@ymail.com'}], 'overallOfficials': [{'name': 'Ronan ABGRAL, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nuclear Medecine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}