Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-01 @ 10:01 AM
Study NCT ID:
NCT06842303
Status:
RECRUITING
Last Update Posted:
2025-07-17
First Post:
2025-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contribution of New Pancreatic MRI Sequences for the Evaluation of Tumor Response in Pancreatic Adenocarcinomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D054459', 'term': 'Elasticity Imaging Techniques'}], 'ancestors': [{'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-06-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2025-02-03', 'studyFirstSubmitQcDate': '2025-02-18', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute elasticity value of the tumor (kPa) before treatment.', 'timeFrame': 'Baseline (J0) before treatment', 'description': "The absolute elasticity value of the tumor corresponds to the average elasticity value measured within the region of interest, which will be outlined according to the tumor's boundaries."}, {'measure': 'Absolute elasticity value of the tumor (kPa) after chemotherapy.', 'timeFrame': '3 months, after chimiotherapy', 'description': "The absolute elasticity value of the tumor corresponds to the average elasticity value measured within the region of interest, which will be outlined according to the tumor's boundaries."}], 'secondaryOutcomes': [{'measure': 'For patient with a resectable pancreatic lesion, evaluation of the association between size of the tumor (mm) with the absolute elasticity value of the tumor (kPa).', 'timeFrame': '3 months, after surgery'}, {'measure': 'For the patients who underwent surgery, evaluation of the association between size of the tumor (mm) and the absolute elasticity value of the tumor (kPa) before chimiotherapy.', 'timeFrame': '6 months, after surgery'}, {'measure': 'For the patients who underwent surgery, evaluation of the association between size of the tumor (mm) and the absolute elasticity value of the tumor (kPa) after chimiotherapy..', 'timeFrame': '6 months, after surgery'}, {'measure': 'For patient with a resectable pancreatic lesion, evaluation of the association between size of the tumor (mm) with the apparent coefficient diffusion (ADC) in mm²/s.', 'timeFrame': '3 months, after surgery'}, {'measure': 'For the patients who underwent surgery, evaluation of the association between size of the tumor (mm) with the apparent coefficient diffusion (ADC) in mm²/s before chimiotherapy..', 'timeFrame': '6 months, after surgery'}, {'measure': 'For the patients who underwent surgery, evaluation of the association between size of the tumor (mm) and the apparent coefficient diffusion (ADC) in mm²/s after chimiotherapy..', 'timeFrame': '6 months, after surgery'}, {'measure': 'Overall survival in years', 'timeFrame': 'At the end of the follow-up period (maximum 24 months).', 'description': 'Time interval between the inclusion date and the date of death from any cause.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreas Adenocarcinomas']}, 'descriptionModule': {'briefSummary': 'Pancreatic adenocarcinoma is the most pessimistic digestive cancer in terms of prognosis. Tumor response assessment is crucial, and the recent development of new magnetic resonance imaging sequences, such as high resolution applied to diffusion sequences (Harder et al., 2022) or magnetic resonance elastography (MRE) (Steinkohl et al., 2021), could help address this issue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CT scan diagnosis of non-metastatic pancreatic cancer on contrast-enhanced thoraco-abdomino-pelvic CT;\n* Adult patient: age ≥ 18 years;\n* Patient affiliated with a social security system or beneficiary of such a system;\n* Patient who has received complete information about the research organization and has signed an informed consent form.\n\nExclusion Criteria:\n\n* Patient with a contraindication to MRI.\n* Person referred to in Articles L. 1121-5, L. 1121-7, and L. 1121-8 of the French Public Health Code.\n\n * Pregnant woman, parturient, or breastfeeding mother;\n * Minor (non-emancipated) individual;\n * Adult individual under legal protection (guardianship, curatorship, or judicial safeguard);\n * Adult individual unable to express consent.\n* Person deprived of liberty by a judicial or administrative decision, or person undergoing psychiatric care pursuant to Articles L. 32-12-1 and L. 3213-1 of the French Public Health Code.'}, 'identificationModule': {'nctId': 'NCT06842303', 'acronym': 'PADME', 'briefTitle': 'Contribution of New Pancreatic MRI Sequences for the Evaluation of Tumor Response in Pancreatic Adenocarcinomas', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Contribution of New Pancreatic MRI Sequences for the Evaluation of Tumor Response in Pancreatic Adenocarcinomas', 'orgStudyIdInfo': {'id': '2024-A01375-42'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient with a resectable pancreatic lesion', 'description': 'Pancreatic resection surgery', 'interventionNames': ['Device: Magnetic resonance elastography (MRE).', 'Device: High-resolution diffusion sequence in MRI']}, {'type': 'EXPERIMENTAL', 'label': 'Patient with a borderline pancreatic lesion', 'description': 'Potential pancreatic resection surgery after chemotherapy.', 'interventionNames': ['Device: Magnetic resonance elastography (MRE).', 'Device: High-resolution diffusion sequence in MRI']}, {'type': 'EXPERIMENTAL', 'label': 'Patient with locally advanced pancreatic lesion.', 'description': 'Chemotherapy treatment.', 'interventionNames': ['Device: Magnetic resonance elastography (MRE).', 'Device: High-resolution diffusion sequence in MRI']}], 'interventions': [{'name': 'Magnetic resonance elastography (MRE).', 'type': 'DEVICE', 'description': 'Magnetic resonance elastography (MRE) is an imaging technique that measures tissue stiffness by assessing the deformation waves produced under external pressure', 'armGroupLabels': ['Patient with a borderline pancreatic lesion', 'Patient with a resectable pancreatic lesion', 'Patient with locally advanced pancreatic lesion.']}, {'name': 'High-resolution diffusion sequence in MRI', 'type': 'DEVICE', 'description': 'High-resolution diffusion sequence in MRI is an imaging technique that uses the movement of water molecules within tissues to generate detailed images.', 'armGroupLabels': ['Patient with a borderline pancreatic lesion', 'Patient with a resectable pancreatic lesion', 'Patient with locally advanced pancreatic lesion.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'state': 'France', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'DROUOT Guillaume', 'role': 'CONTACT', 'email': 'g.drouot@chru-nancy.fr', 'phone': '0383157666'}, {'name': 'Julie LECLERC, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHRU Nancy', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'Guillaume DROUOT, PhD', 'role': 'CONTACT', 'email': 'g.drouot@chru-nancy.fr', 'phone': '0385157666', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'LECLERC Julie', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}