MISOBOLD - Prostate cancer hypoxia using BOLD MRI and 18F-FMISO PET imaging
- Conditions
- Prostate cancerMedDRA version: 20.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-000377-12-FR
- Lead Sponsor
- CHU de Bordeaux
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
• Patient above 18 yrs old.
• Prostate tumor with histological confirmed diagnosis and highly radiological suspected target on MRI
• High risk patient : >T2c grade, Glasgow score > 7 and PSA > 20ng/ml
• Surgical treatment chosen during multidisciplinary meeting
• ECOG =2
• Patient must have undergone MRI with BOLD sequence less than 6 month prior surgery
• Informed signed consent.
• Member or beneficiary of a social security system.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
• Patient included in another clinical study
• Geographical, social or psychological reasons preventing patient from submitting to the study’s medical monitoring
• Patient deprive of liberty, adult subjects to legal protection or unable to give consent
• Contraindication to MRI
• Contraindication to gadolinium injection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method