Condition category
Nutritional, Metabolic, Endocrine
Date applied
26/01/2006
Date assigned
07/02/2006
Last edited
28/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

University College London (UK)

Sponsor details

Gower street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

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

  1. 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.

Additional files

Editorial Notes