Ignite Creation Date:
2025-12-24 @ 2:21 PM
Ignite Modification Date:
2026-02-28 @ 10:35 PM
Study NCT ID:
NCT02516995
Status:
COMPLETED
Last Update Posted:
2016-02-10
First Post:
2015-08-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Magnetic Resonance Imaging for High Throughput Curietherapy Planning in Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-09', 'studyFirstSubmitDate': '2015-08-03', 'studyFirstSubmitQcDate': '2015-08-04', 'lastUpdatePostDateStruct': {'date': '2016-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of imaging [good/good enough/not good enough]', 'timeFrame': 'Assessed six weeks after inclusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Merge the data of ultrasound with that of the anatomical and functional MRI is necessary since the high dose rate Curietherapy is carried out under ultrasound guidance. The investigators will recruit prostate cancer patients to evaluate the quality of the data, their sensitivity to exam conditions (patient position, volume of endorectal probe, gold grains implanted before intensity modulated radiotherapy , IMRT) and to merge data from different sources with the purpose of estimating the opportunities of integration treatment plan for Curietherapy broadband.\n\nThe nuclear magnetic resonance imaging provides precise anatomical study, but also provides access to a functional approach to the tumor mapping of water diffusion coefficient (DW-MRI), for dynamic imaging with injection contrast agent (DCE-MRI) and finally by spectroscopic imaging (IRMS). This multimodality imaging project is part of a multidisciplinary context, involving close collaboration between clinicians, medical physicists, and physicists of the teams participating in this project (Institut Gustave Roussy and U2R2M-CIERM hospital Kremlin-Bicetre).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients with prostate cancer biopsy-proven, intermediate or high risk (according to D'Amico Classification), for which radiotherapy is indicated.\n\n* Accepting the imaging tests.\n* Age \\<70 years.\n* Informed consent signed.\n\nExclusion Criteria:\n\n* Mental pathology that can interfere with the proper conduct of the study;\n* Claustrophobia;\n* Severe heart or respiratory disorder that can make it difficult to achieve relatively long imaging tests\n* Contraindications to magnetic resonance imaging (MRI)\n\n 1. pacemaker, other electronic appliance (depending on model);\n 2. heart valve, intra-cranial clip aneurysm, cerebral ventricular bypass valve (depending on model);\n 3. intraocular metallic foreign bodies (chips), and other locations, according to the site to discuss.\n 4. metal tracheostomy cannula;\n 5. endovascular stent or vascular embolization coils placed within six weeks in advance;\n 6. the impediments to a long examination with spectroscopy sequence of ten to twenty minutes: major tremors, inability to lie more than 30 minutes;\n 7. local sources of magnetic distortion which is sensitive spectroscopic imaging: hip replacement, prostate biopsy older than six weeks."}, 'identificationModule': {'nctId': 'NCT02516995', 'acronym': 'FIBROP', 'briefTitle': 'Functional Magnetic Resonance Imaging for High Throughput Curietherapy Planning in Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Gustave Roussy, Cancer Campus, Grand Paris'}, 'officialTitle': 'Functional Magnetic Resonance Imaging for High Throughput Curietherapy Planning in Prostate Cancer', 'orgStudyIdInfo': {'id': '2010-A00440-39'}, 'secondaryIdInfos': [{'id': '2010/1630', 'type': 'OTHER', 'domain': 'CSET number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with prostate cancer', 'interventionNames': ['Device: Functional magnetic resonance imaging', 'Device: Ultrasound']}], 'interventions': [{'name': 'Functional magnetic resonance imaging', 'type': 'DEVICE', 'armGroupLabels': ['Patients with prostate cancer']}, {'name': 'Ultrasound', 'type': 'DEVICE', 'armGroupLabels': ['Patients with prostate cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94805', 'city': 'Villejuif', 'state': 'Val de Marne', 'country': 'France', 'facility': 'Gustave Roussy Cancer Campus Grand Paris', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gustave Roussy, Cancer Campus, Grand Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}