Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-03-06 @ 10:09 PM
Study NCT ID:
NCT03293602
Status:
WITHDRAWN
Last Update Posted:
2019-11-27
First Post:
2017-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MISOBOLD - Prostate Cancer Hypoxia Using BOLD MRI and 18F-MISO PET Imaging
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'the team has changed. the new team did not have the perosnnel to set up the study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-25', 'studyFirstSubmitDate': '2017-09-20', 'studyFirstSubmitQcDate': '2017-09-20', 'lastUpdatePostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'comparison between histological results and oxygenation quantitative values from MRI and PET exams', 'timeFrame': 'Inclusion, 1 month', 'description': 'Correlation study between anatomopatology data, product by prostatectomy anatomic piece, using HIF1-CAIX histological markers and:\n\n* on one hand PET FMISO uptake\n* on the other hand, MRI BOLD signal'}], 'secondaryOutcomes': [{'measure': 'quantitative analysis', 'timeFrame': 'Inclusion, 1 month', 'description': 'a quantitative analysis of inter-individual variability will be done in order o compare inter-individual variability of hypoxia measures between the two imaging modalities'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prostate cancer', 'MRI', 'BOLD', '18F-MISO', 'PET'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This feasibility exploratory study objective is to assess the ability of combined MRI BOLD and 18F-MISO PET imaging to visualize tumor hypoxia compare to histological results obtained after radical prostatectomy in order to, in time, be able to identify patient with bad prognostic and to offer them the best therapeutic strategy.', 'detailedDescription': 'Prostate cancer is the fisrt one in male with 80.000 new cases each year in France. Forty thousand curative treatments are performed each year, but 25 to 30% of these patients will present a cancer reccurence after radical surgery or conformationnal radiotherapy, Tissu hypoxia seems to be mainly responsible of the local reccurence and conduct to molecular damages that creates carcinogenesis and tumor agressitivity. This hypoxia inhibits the DNA healing and the apoptosis but increases the angiogenesis, that leads to treatment resistance. L. Marignol \\&al clearly showed that hypoxia may have a main role in hormonal resistance. Furthermore, M. Milosevic \\& al showed that hypoxia is an independent factor of local reccurence after radiotherapy. Nowadays, new technics of IMRT in radiotherapy planning could be able to target an hypoxic prostate region to prevent reccurence. Patients who are eligible to radical prostatectomy will benefit of a prostate MRI with BOLD sequences and a 18F-misonidazole PET before surgery. The results of these two technics will be compared to the histological results using CAIX and HIF immunohistochemistery markers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient above 18.\n* Prostate tumor with histological confirmed diagnosis and highly radiological suspected target on MRI\n* High risk patient : \\>T2c grade, Glasgow score \\> 7 and PSA \\> 20ng/ml\n* Surgical treatment chosen during multidisciplinary meeting\n* ECOG ≤2\n* Patient must have undergone MRI with BOLD sequence less than 6 month prior surgery\n* Member or beneficiary of a social security system.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Patient included in another clinical study\n* Geographical, social or psychological reasons preventing patient from submitting to the study's medical monitoring\n* Patient deprive of liberty, adult subjects to legal protection or unable to give consent\n* Contraindications to MRI\n* Contraindication to gadolinium injection"}, 'identificationModule': {'nctId': 'NCT03293602', 'acronym': 'MISOBOLD', 'briefTitle': 'MISOBOLD - Prostate Cancer Hypoxia Using BOLD MRI and 18F-MISO PET Imaging', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'MISOBOLD - Prostate Cancer Hypoxia Using BOLD MRI and 18F-MISO PET Imagin', 'orgStudyIdInfo': {'id': 'CHUBX 2014/26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'F-MISO PET imaging', 'description': 'F-MISO PET imaging will be added to the preoperative staging explorations of a patient with high risk prostate cancer candidate to radical prostatectomy. Patient will be selected during multidisciplinary meeting and urology consultation of Bordeaux and Toulouse university hospitals. Functional MRI imaging should be available before surgery. If patient consent to participate in the study, F-MISO PET imaging will be planed before prostatectomy. Results of this exam will not be considered for patient therapeutic management.', 'interventionNames': ['Device: F-MISO PET imaging']}], 'interventions': [{'name': 'F-MISO PET imaging', 'type': 'DEVICE', 'description': 'F-MISO PET imaging will be added to the preoperative staging explorations of a patient with high risk prostate cancer candidate to radical prostatectomy. Patient will be selected during multidisciplinary meeting and urology consultation of Bordeaux and Toulouse university hospitals. Functional MRI imaging should be available before surgery. If patient consent to participate in the study, F-MISO PET imaging will be planed before prostatectomy. Results of this exam will not be considered for patient therapeutic management.', 'armGroupLabels': ['F-MISO PET imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31300', 'city': 'Toulouse', 'country': 'France', 'facility': 'Centre de Lutte Contre le Cancer', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cancéropôle GSO and GIRCI SOOM (API-K)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}