Evaluation of 68Ga-PSMA PET-CT in the initial extension assessment of advanced renal cell carcinomaa prospective, multicenter, open study
- Conditions
- renal cell cancer (RCC)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-003760-47-FR
- Lead Sponsor
- Assistance Publique Hôpitaux de Marseille
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 44
• Age = 18 years,
• newly diagnosed patient for localized RCC intermediate or high risk (prognostic system UISS) or metastatic kidney cancer (M1 according to the TNM staging) with histological evidence (biopsy or surgical removal of part).
• Recent conventional imaging review (from 1 month maximum on PET day at 68Ga-PSMA):
- cerebral CT, chest and abdominopelvic CT with iodine injection comprising an arterial and portal and late time;
- bone scintigraphy.
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14
• Pregnant or lactating woman;
• History of other evolutionary neoplasia known in the previous 2 years
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