Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-31 @ 4:53 PM
Study NCT ID:
NCT04520932
Status:
RECRUITING
Last Update Posted:
2025-05-25
First Post:
2020-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Pancreatic Neuroendocrine Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007516', 'term': 'Adenoma, Islet Cell'}], 'ancestors': [{'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 82}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2031-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-23', 'studyFirstSubmitDate': '2020-08-17', 'studyFirstSubmitQcDate': '2020-08-17', 'lastUpdatePostDateStruct': {'date': '2025-05-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment response', 'timeFrame': '1 year', 'description': 'Complete response rate to radiofrequency treatment defined by the absence of enhancement with the contrast agent and/or the disappearance of the lesion on imaging.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Radio Frequency treatment', 'Echoendoscopy', 'Ablation', 'Efficacy'], 'conditions': ['Neuroendocrine Tumor of Pancreas (Disorder)', 'Neuroendocrine Tumor Grade 1']}, 'descriptionModule': {'briefSummary': 'Pancreatic radiofrequency ablation (RFA) could therefore be an alternative to the monitoring of pancreatic neuroendocrine tumors (PNETs) and more particularly nonfunctioning PNETs (NF-PNETs), which is costly and anxiety-inducing for patients. To date, only a few small studies have evaluated this treatment and the results are encouraging. It appears necessary to consider a large-scale study to ensure the efficacy and low morbidity of pancreatic RFA applied to PNETs.', 'detailedDescription': 'The primary objective of the study is to evaluate the efficacy of radiofrequency treatment of grade 1 NF-PNETS with a size less than or equal to 2cm.\n\nPatients meeting the selection criteria will be included in the study after signing the consent. They will benefit from a RFA treatment consisting of 1 to 3 sessions depending on their response to the treatment. Patients will then be followed for 5 years in order to evaluate their response to treatment, their clinical evolution, their quality of life and any complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pancreatic mass of less than 2cm on MRI, or CT scan if contraindicated by MRI;\n* Diagnosis of neuroendocrine tumor on biopsy under high echo-endoscopy (HEE) with Ki67\\<3%,\n* Non-secretory lesion.\n* Homogeneous HEE contrast taking;\n* No positron emission tomography (PET) FDG binding to the pancreatic mass;\n* Lesion \\<20mm on conventional imaging at 6 months monitoring;\n* Age 18 to 80 years inclusive;\n* Patient in good general condition, World Health Organization \\[0-1\\];\n* Signed consent to participate;\n* Affiliation to healthcare insurance system or beneficiary of this regimen.\n\nExclusion Criteria:\n\n* Pregnant or likely to become pregnant (without effective contraception) or breastfeeding ;\n* A person in an emergency situation or deprived of liberty or placed under the authority of a tutor.\n* Life expectancy \\< 1 year;\n* Severe hemostasis disorders;\n* Pancreatic and/or biliary ductal dilation;\n* Lesion considered to be adjacent to the pancreatic duct and/or bile duct;\n* Node extension and/or metastatic disease;\n* Patient being managed for another malignant lesion which is progressive or under treatment.'}, 'identificationModule': {'nctId': 'NCT04520932', 'acronym': 'RFANET', 'briefTitle': 'Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Pancreatic Neuroendocrine Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Institut Paoli-Calmettes'}, 'officialTitle': 'Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Low Grade Pancreatic Neuroendocrine Tumors of Less Than 2cm in Size', 'orgStudyIdInfo': {'id': 'RFANET-IPC 2020-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RFA treatment efficacy', 'description': 'PNETs ablation by radiofrequency treatment (1 to 3 sessions)', 'interventionNames': ['Procedure: Radiofrequency ablation']}], 'interventions': [{'name': 'Radiofrequency ablation', 'type': 'PROCEDURE', 'description': 'RFA is performed under general anaesthesia, under high endoscopic echo-endoscopy (EEH), in left lateral decubitus position, using the StarMed generator from Taewong®.', 'armGroupLabels': ['RFA treatment efficacy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13009', 'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jihane PAKRADOUNI', 'role': 'CONTACT', 'email': 'drci.up@ipc.unicancer.fr', 'phone': '+ 33 4 91 22 37 78'}, {'name': 'Delphine MARIE', 'role': 'CONTACT', 'email': 'drci.up@ipc.unicancer.fr', 'phone': '+ 33 4 91 22 37 78'}], 'facility': 'Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Jihane PAKRADOUNI', 'role': 'CONTACT', 'email': 'drci.up@ipc.unicancer.fr', 'phone': '+33491223778'}], 'overallOfficials': [{'name': 'Fabrice CAILLOL, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Paoli Calmettes Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Paoli-Calmettes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}