Contact information
Type
Scientific
Primary contact
Dr Laurence Lovat
ORCID ID
Contact details
National Medical Laser Centre
Charles Bell House
67-73 Riding House Street
London
W1W 7EJ
United Kingdom
med.laser@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 3.1
Study information
Scientific title
Acronym
Study hypothesis
To determine whether photodynamic therapy for high grade dysplasia in Barrett's oesophagus using aminolaevulinic acid has less side effects than photofrin. To develop novel measures of efficacy.
Ethics approval
Berkshire Research Ethics Committee, 13/01/2006, ref: 05/Q1602/193
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
High grade dysplasia in Barrett's oesophagus
Intervention
Photodynamic therapy using 5-aminolaevulinic acid versus photofrin
Intervention type
Drug
Phase
Not Specified
Drug names
Aminolaevulinic
Photofrin
Primary outcome measures
1. Eradication of high grade dysplasia
2. Prevention of oesophageal cancer
3. Side effect profiles of different types of photodynamic therapy
Secondary outcome measures
1. Quality of life outcomes
2. Develop novel methods for treatment efficacy
3. Reversal of Barrett's oesophagus
Overall trial start date
01/02/2006
Overall trial end date
01/02/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with high grade dysplasia in Barrett's oesophagus but without invasive cancer
2. Aged over 21
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
66
Participant exclusion criteria
1. Severe cardiovascular disease
2. Liver cirrhosis or seriously impaired hepatic or renal function
3. Depot antipsychotics
4. Concomitant chemoradiotherapy
5. Pregnancy
6. Porphyria
7. Previous photodynamic therapy
Recruitment start date
01/02/2006
Recruitment end date
01/02/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
National Medical Laser Centre
London
W1W 7EJ
United Kingdom
Funders
Funder type
Government
Funder name
National Medical Laser Centre (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22699800
Publication citations
-
Results
Dunn JM, Mackenzie GD, Banks MR, Mosse CA, Haidry R, Green S, Thorpe S, Rodriguez-Justo M, Winstanley A, Novelli MR, Bown SG, Lovat LB, A randomised controlled trial of ALA vs. Photofrin photodynamic therapy for high-grade dysplasia arising in Barrett's oesophagus., Lasers Med Sci, 2013, 28, 3, 707-715, doi: 10.1007/s10103-012-1132-1.