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

ISRCTN	ISRCTN14275387
DOI	https://doi.org/10.1186/ISRCTN14275387
Protocol serial number	04/QO603/42
Sponsor	Guy's Hospital - Research and Development Department (UK)
Funder	Guy's and St Thomas' Charity (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Timothy O'Brien
Scientific

Dept. Urology
1st Floor Thomas Guy House
Guy's Hospital
St Thomas' Street
London
SE1 9RT
United Kingdom

Phone	+44 (0)207 1886796
Email	tim.obrien@gstt.nhs.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	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
Study objectives	The aim is to determine if photodynamic assisted resection can reduce the recurrence rate of tumour at one year when compared with the control group. The primary endpoint is the diagnosis of recurrent tumour at 3 months or 12 months on check cystoscopy.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Bladder cancer
Intervention	Intervention: Pre-operative intravesical instillation of solution of hexylaminolevulinic acid (HAL) - photodynamic 'bluelight' assisted resection of bladder tumours Control: Conventional 'whitelight' transurethral resection
Intervention type	Drug
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Hexyl aminolevulinic acid (HAL)
Primary outcome measure(s)	Recurrence rates of bladder tumour at 3 months and 12 months post surgery
Key secondary outcome measure(s)	Analysis of histology
Completion date	01/02/2007

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	200
Key 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
Key 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
Date of first enrolment	01/02/2005
Date of final enrolment	01/02/2007

Guy's Hospital

London
SE1 9RT
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes