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A randomised study of 'bluelight' hexyl aminolevulinic acid (HAL) photodynamic assisted resection of bladder tumours versus conventional 'whitelight' transurethral resection of newly diagnosed bladder tumours comparing rates of tumour recurrence over one year - a Phase IV trial

A randomised study of 'bluelight' hexyl aminolevulinic acid (HAL) photodynamic assisted resection of bladder tumours versus conventional 'whitelight' transurethral resection of newly diagnosed bladder tumours comparing rates of tumour recurrence over one year - a Phase IV trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14275387
Enrollment
200
Registered
2005-09-02
Start date
2005-02-01
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Bladder cancer Cancer Malignant neoplasm of bladder

Interventions

Intervention: Pre-operative intravesical instillation of solution of hexylaminolevulinic acid (HAL) - photodynamic 'bluelight' assisted resection of bladder tumours Control: Conventional 'whitelight'

Sponsors

Guy's Hospital - Research and Development Department (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. New diagnosis of bladder tumour - the study is designed to reduce recurrence rates in newly diagnosed cases of bladder tumours 2. Superficial disease - the study will address the recurrence rates in superficial bladder cancer 3. No history of previous bladder surgery - previous surgical procedures to the bladder may cause artifactual changes when using 'blue light' cystoscopy 4. Life expectancy of at least 1-year - study duration will be for 1-year

Exclusion criteria

Exclusion criteria: 1. Previous bladder tumour or coexisting/previous upper tract disease - the study is designed to reduce recurrence rates in newly diagnosed cases of bladder tumours 2. Muscle invasive disease - the study will address the recurrence rates in superficial bladder cancer 3. Previous bladder surgery -previous surgical procedures to the bladder may cause artifactual changes when using 'blue light' cystoscopy

Design outcomes

Primary

MeasureTime frame
Recurrence rates of bladder tumour at 3 months and 12 months post surgery

Secondary

MeasureTime frame
Analysis of histology

Countries

United Kingdom

Outcome results

None listed

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