uPAR-PET/MRI in patients with prostate cancer for evaluation of tumor aggressiveness
Phase 1
- Conditions
- Prostate cancerMedDRA version: 20.0Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- EUCTR2017-002276-37-DK
- Lead Sponsor
- Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine & PET
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Male
- Target Recruitment
- 52
Inclusion Criteria
- Histologically verified prostate cancer or clinical suspicion of prostate cancer based on biochemical parameters and/or digital rectal examination
- Written and oral consent
- Age = 18 years
- Planned or ongoing Active Surveillance regimen or planned therapy with curative intent (radical prostatectomy or radiotherapy)
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 32
Exclusion Criteria
- Obesity (body weight > 140 kg)
- Known allergy towards 68Ga-NOTA-AE105
- Severe claustrophobia
- Implanted metal components or devices incompatible with MRI
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