Clinical trial · Interventional
Detection of Bladder Tumors After 30 Min Instillation of Hexvix
Open Prospective Within Patient, Phase IIa Study of Hexvix Flexible Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer After 30 Minutes Instillation of Hexvix in Patients With Known or Suspicion of Bladder Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow inclusion rate
Summary
Brief summary (as posted)
The objective of the study is to compare Hexvix® flexible cystoscopy and white light flexible cystoscopy in the detection of histological confirmed bladder tumor lesions defined as dysplasia; CIS; Ta; T1; and ≥ T2 after 30 minutes intravesical instillation of Hexvix®.
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 |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hexvix | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of lesions
- timeFrame
- An average of 15 min (during cystoscopy)
Secondary outcomes (1)
- measure
- Drug related adverse events
- timeFrame
- From time of drug instillation until 24 hours after cystoscopy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: The patients should be indicated for a transurethral resection of the bladder (TURB) based on an outpatient cystoscopy and fulfil the following inclusion criteria: * Patients with multiple bladder tumors, defined as ≥2 lesions, based on an outpatient cystoscopy. * Patients with known urinary urge symptoms or patients who have problems or pain holding back the urine for a time longer than 30 minutes. * Age 18 years or above Exclusion Criteria: * Patients with known tumors in the prostatic urethra or distal urethra * 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 fluorescence cystoscopy. Where the bleed is light, the patient should not be excluded if in the investigator's opinion, rinsing during cystoscopy will alleviate the possible interference with fluorescence cystoscopy). * Patient with porphyria. * Hypersensitivity to the active substance or to any of the excipients of the solvent * Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days. * Women of child-bearing potential meaning that only post-menopausal women, women who had their ovaries removed, and women who are otherwise physically unable to bear children can be included. * Patients who have received BCG or chemotherapy within three months prior to study inclusion. * Conditions associated with a risk of poor protocol compliance. * Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol * Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the clinical study. * Patients unlikely to comply with protocol
References
Publications (0)
Data not yet available