A randomised Study of “bluelight” hexyl amino levulinic acid (HAL) photodynamic assisted resection of bladder tumours versus conventional “white light” transurethral resection of newly diagnosed bladder tumours comparing rates of tumour recurrence over one year – A phase IV trial - HEXVIX Blue light

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-002760-16-GB

Enrollment

312

Registered

2005-02-17

Start date

2005-01-12

Completion date

Unknown

Last updated

2018-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Superficial Bladder Cancer MedDRA version: 9.1 Level: LLT Classification code 10005003 Term: Bladder cancer

Interventions

Trade Name: Hexvix Product Name: Hexvix Pharmaceutical Form: Powder for bladder irrigation INN or Proposed INN: hexaminolevulinate hydrochloride. Concentration unit: mg milligram(s) Concentration type

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Randomised Trial: New patient with superficial bladder transitional cell carcinoma (TCC) for transurethral resection Subsidiary studies: i). Patient for check cystoscopy following a course of BCG for superficial bladder tumour. ii). Previous investigation: upper tract imaging, cystoscopic assessment. Positive urine cytology. iii). Recurrent bladder tumour diagnosed on flexible cystoscopy and/or suspected by positive urine cytology. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Randomised Trial: Previous bladder tumour or upper tract TCC Previous bladder surgery Life expectancy less than one year Subsidiary studies: None

Design outcomes

Primary

Measure	Time frame
Main Objective: To test the hypothesis that photodynamic assisted resection of superficial bladder cancer reduces the recurrence rate. ;Secondary Objective: ;Primary end point(s): Randomised trial: Check cystoscopy at one year Subsidary Studies: Diagnosis of additional histologically confirmed tumour when using bluelight cystoscopy over white light cystoscopy	—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026