Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT01471002
Status:
COMPLETED
Last Update Posted:
2016-04-08
First Post:
2011-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Efficacy of Percutaneous Cryoablation for Renal Tumours < 4cm in Patients Who Are Not Candidates for Partial Nephrectomy
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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-07', 'studyFirstSubmitDate': '2011-11-03', 'studyFirstSubmitQcDate': '2011-11-09', 'lastUpdatePostDateStruct': {'date': '2016-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Suspicious contrast enhancement and progression in size of the cryolesion detected by MRI', 'timeFrame': '1 year', 'description': 'The success of cryoablation will be declared if the control at 1 year shows no suspicious contrast enhancement (the suspicious character is defined by significant contrast uptake (\\>15%) and heterogeneous or nodular or crescent-shape contrast enhancement) and if the cryolesion is not progressing in size compared to early post-ablation control (M1).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Renal Tumors Less Than 4 cm']}, 'descriptionModule': {'briefSummary': 'The main objective is to evaluate the oncologic efficacy of percutaneous cryoablation of renal tumors smaller than 4 cm in patients with renal cancer that cannot be offered a partial nephrectomy. The oncologic outcome will be assessed by the presence or absence of residue or recurrence during a follow-up by MRI performed the first 12 months (M1, M3, M6, M12).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients should have the following characteristics:\n\n* About 75 years, or\n* Whatever the age:\n\n * A context of family-type tumor (VHL, hereditary carcinoma, tubulo-papillary ...);\n * or solitary kidney, when the tumor is not easily accessible for nephron-sparing surgery: Malignant centro-hilar or intra-parenchymal;\n * or in a local recurrence (single or multiple) after partial nephrectomy (within a limit of 3 tumors to be treated);\n * or in a subject with impaired renal function and therefore at risk of severe renal insufficiency (risk defined by a creatinine clearance below 30 ml / min by MDRD formula);\n * and who do not present any contra-indication for cryoablation treatment.\n\nThe tumor(s) should meet the following criteria:\n\n* Presence of one to three solid tumors of the native renal parenchyma with a largest diameter less than (or equal to) 40 mm, which corresponds to a maximum volume of about 32 cc, as measured by MRI.\n* A preoperative MRI is essential since this technique presents a higher sensitivity. This control will also give more consistency to the evaluation of the radiological semiology at follow-up.\n* And its/their location(s) will be accessible to a percutaneous approach.\n\nThe search of metastases, including a thoracic CT scan, should be negative.\n\nExclusion Criter ia:\n\n* \\- Partial nephrectomy feasible in good technical and oncologic conditions in patients under 75 years and in the absence of family tumors.\n* Contraindication to any form of sedation.\n* Irreversible coagulopathy\n* Tumor\\> 4cm\n* Contraindication to MRI or gadolinium (proven allergy). NB: Patients with a glomerular filtration rate below 30 ml/min/1, 73 m2 will be injected with a single dose of the macrocyclic gadolinium with the highest thermodynamic stability (Dotarem or Prohance), given the united recommendations of AFSSAPS and EMA (European Medicines Agency) \\[45\\]. On the contrary, the linear molecules of gadolinium, due to their lower stability, will be contra-indicated because of the risk of systemic nephrogenic fibrosis (FNS).\n* Recurrence on the same location after a procedure performed out of the thermoablation protocol.\n* Biopsy proven benign tumor\n* Predominantly cystic tumor, defined by a necrotic content constituting over one third of tumor volume\n* Presence of endo-venous extension, of proven secondary extensions, visceral or in the lymph nodes (especially lung). In this regard, a thoracic CT scan will be routinely required before treatment, according to the recommendations of urological societies.\n* Psychiatric disorders and adults under guardianship\n* Pregnancy or breastfeeding\n* Minor patients\n* Legal safeguard\n* Participation in another clinical trial'}, 'identificationModule': {'nctId': 'NCT01471002', 'acronym': 'CRYOREIN', 'briefTitle': 'Study to Evaluate the Efficacy of Percutaneous Cryoablation for Renal Tumours < 4cm in Patients Who Are Not Candidates for Partial Nephrectomy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Prospective Study to Evaluate the Efficacy of Percutaneous Cryoablation for Renal Tumours < 4cm in Patients Who Are Not Candidates for Partial Nephrectomy', 'orgStudyIdInfo': {'id': '5062'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Renal cancer without nephrectomy', 'description': 'patients with renal cancer that cannot be offered a partial nephrectomy', 'interventionNames': ['Device: Galil Medical patented 17G Cryoablation Needles']}], 'interventions': [{'name': 'Galil Medical patented 17G Cryoablation Needles', 'type': 'DEVICE', 'armGroupLabels': ['Renal cancer without nephrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'state': 'Alsace', 'country': 'France', 'facility': 'Nouvel Hôpital Civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Afshin GANGI, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpitaux Universitaires de Strasbourg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}