Clinical trial · Interventional
Hexvix Photodynamic Therapy in Patients With Bladder Cancer
A Phase I Feasibility Study of Hexvix Photodynamic Therapy in Patients With Intermediate or High-risk Bladder Cancer
NCT01303991CI-TRIAL-00004473completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to investigate the safety and feasibility of Hexaminolevulinate based photodynamic therapy in patients with intermediate or high-risk transitional cell carcinoma of the bladder.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intermediate or High-risk Bladder Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hexvix PDT with Karl Storz T-Light | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hexvix PDT
- interventionNames
- Other: Hexvix PDT with Karl Storz T-Light
Primary outcomes (1)
- measure
- Number of patients with adverse events
- description
- To assess the safety of photodynamic therapy (PDT) using Hexvix and the Karl Storz T-light PDT System in patients with recurrent bladder cancer. (assessment of adverse events, blood biochemistry, vital signs, urodynamics)
Secondary outcomes (1)
- measure
- The number of tumour-free patients after 6 months
- description
- To assess the efficacy of Hexvix PDT in patients with intermediate and high-risk bladder cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female aged 18 years or above who have given written informed consent. * Patients with intermediate or high-risk superficial bladder cancer, defined as low-grade early recurrence within 6 months after local chemotherapy or BCG, primary or recurrent high-grade disease (TaG3, TaG3 with CIS or CIS alone) or patients with primary T1G3 who are tumour free at second resection. Exclusion Criteria: * Patients with muscle invasive tumour * Patients with bladder shrinkage * Patients who have received prior PDT for bladder cancer * History of T1G3 disease or other indications for cystectomy * Patient with porphyria * Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with PDT) * Patients who have received BCG or chemotherapy within three months prior to Hexvix instillation, except for a single dose of chemotherapy for prevention of seeding after resection * Known allergy to hexaminolevulinate or a similar compound * Participation in other clinical studies either concurrently or within the last 30 days * Women of child-bearing potential. * Conditions associated with a risk of poor protocol compliance
References
Publications (0)
Data not yet available
No reference posted for this study.