EUCTR2015-000436-15-DKActive, not recruitingPhase 1
Photodynamic diagnosis (PDD) in flexible cystoscopy – a randomized study with focus on significant recurrence
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Aarhus Universitet
- Enrollment
- 696
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •age over 18 years
- •first time TUR-B where the pathology showed Ta ( LG and HG)
- •informed consent on the basis of oral and written information
- •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 696
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 696
Exclusion Criteria
- •lack of consent
- •communication problems
- •missing or incomplete implementation of the procedure and Hexvix installation
- •active cystitis
- •catheter in the bladder ( chronic)
- •AK treatment apart from aspirin
- •Treatment with BCG in the meantime between TUR-B and study inclusion
Investigators
Similar Trials
Completed
Phase 3
Photodynamic Diagnosis (PDD) in Flexible CystoscopyRecurrenceBladder CancerPDDNCT02660190Jørgen Bjerggaard Jensen696
Completed
Not Applicable
Photodynamic diagnosis (PDD) of Peritoneal disseminations of gastric cancer using intraoperative fluorescence laparoscopy with 5-ALA administration.gastric cancerJPRN-UMIN000026788Tokyo Metropolitan Tama Medical Center12
Completed
Not Applicable
PhotoDynamic Diagnosis (PDD) and results of biopsies in flexible cystoscopy of bladder tumour patients in an Out-Patient Department set upCancerISRCTN88551578Frederiksberg Hospital (Denmark)37
Unknown
Phase 3
A Phase III of Photodynamic Diagnosis of Bladder Cancer using Fluorescence Cystoscopy with SPP-005 (5-ALA)on-muscle invasive bladder cancerJPRN-jRCT2080222877SBI Pharmaceuticals Co., Ltd.60
Recruiting
Phase 3
Photodynamic diagnosis of non muscle invasive bladder cancer using fluorescence cystoscopy with oral administration of 5-aminolevulinic acid(5-ALA)on muscle invasive bladder cancerJPRN-UMIN000010798Department of urology and Andrology, Kansai Medical University30