Phase II trial: uPAR PET/CT and FDG PET/MRI for determining lymph node metastases in patients with bladder cancer
Phase 1
- Conditions
- rinary bladder cancerMedDRA version: 19.0Level: LLTClassification code 10005004Term: Bladder cancer NOSSystem Organ Class: 100000004864Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Registration Number
- EUCTR2016-001026-33-DK
- Lead Sponsor
- Rigshospitalet, Department of Clinical Physiology, Nuclear Medicine and PET
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Biopsy-verified urinary bladder cancer
The participants must be capable of understanding and giving full informed written consent
age above 18 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35
Exclusion Criteria
Pregnancy
Lactation/breast feeding
Age above 85 years old
Weight above 140 kg
Treatment with neoadjuvant chemotherapy
Known allergy towards 68Ga-NOTA-AE105
Other malignant disease within last 5 years, except for non-melanoma skin cancer
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