Condition category
Cancer
Date applied
04/04/2013
Date assigned
04/04/2013
Last edited
04/10/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Prof David Jayne

ORCID ID

Contact details

University of Leeds & Leeds Teaching Hospitals NHS Trust
Section of Translational Anaesthesia & Surgery
Beckett Street
Leeds
LS9 7TF
United Kingdom
d.g.jayne@leeds.ac.uk

Additional identifiers

EudraCT number

2012-002623-15

ClinicalTrials.gov number

Protocol/serial number

14209

Study information

Scientific title

GLiSten: Next generation intraoperative lymph node staging for stratified colon cancer surgery - development phase

Acronym

GLiSten

Study hypothesis

The study is looking at the use of 5-aminolevulinic acid (5-ALA) in bowel cancer. 5-ALA will not be used to treat the cancer but used during the operation to detect the cancer along with any spread to lymph nodes that surround the bowel as it is preferentially taken up into cancer cells. 5-ALA will be given as a drink approximately 4 hours before surgery and it is thought that any cancer cells in the bowel and in the lymph nodes will glow red under a blue light.

The surgical specimen will be pathologically reviewed and the areas with confirmed cancer cells will be compared to areas that glowed red to see how accurately the substance (5-ALA) detects bowel cancer.

5-ALA has been used extensively before in other cancers, such as bladder cancer, brain tumours, and ovarian cancer. It has only been used before on a very small scale in colorectal cancer.

The study will first run as a Development phase to standardize the techniques, in two centres (Leeds and Dublin), recruiting at least 30 patients with positive lymph nodes. The trial will then expand to an Evaluation phase at approximately 8 centres recruiting 300 patients.

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=14209

Ethics approval

NRES Committee London - South East, 20/03/2013, ref: 13/LO/0214

Study design

Non-randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: National Cancer Research Network; Subtopic: Colorectal Cancer; Disease: Colon

Intervention

Oral 5-ALA solution will be administered at 4-6 hrs prior to the participant's operation.

Follow Up Length: 1 month(s)

Intervention type

Drug

Phase

Not Applicable

Drug names

5-aminolevulinic acid

Primary outcome measures

Identification of the optimal dose for oral administration of 5-ALA for the accurate intra-operative; Timepoint(s): November 2014

Secondary outcome measures

1. Standardisation of preoperative CT reporting, with emphasis on lymph node evaluation
2. Standardisation of operative procedure including D3 lymphadenectomy
3. Optimisation and standardisation of fluorescence detection system
4. Standardisation of pathological lymph node mapping and step sectioning for in depth lymph node evaluation
5. Patient factors affecting the accuracy of 5-ALA fluorescence diagnosis
6. Safety

Overall trial start date

01/06/2013

Overall trial end date

30/11/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Able to give informed consent and willing to follow trial protocol
2. Aged over 18
3. Patients with cancers of the right and sigmoid colon amenable to laparoscopic resection incorporating D3 lymphadenectomy, as agreed by MDT discussion following histopathological diagnosis and radiological staging. Where possible, the study population will be enriched with locally advanced colon cancers to obtain as much information as possible on 5-ALA Fluorescence diagnosi (FD) for lymph node metastases.
4. Patients with distant metastatic disease will be eligible, provided laparoscopic resection of the cancer is part of routine clinical care.
5. Fit for standard laparoscopic resection
6. American Society of Anesthesiologists (ASA) classification <= 3
7. Normal hepatic and renal function
7.1. Total bilirubin within normal institutional limits, AST/ALT < 2.5 X institutional upper limit of normal
7.2. Creatinine within normal institutional limits

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 52; UK Sample Size: 26

Participant exclusion criteria

1. Patients with cancers of the transverse and left colon (due to difficulty in defining D3 lymphadenectomy in these anatomical locations)
2. Past history of hypersensitivity reactions to 5-ALA or colorimetric dye.
3. Acute or chronic porphyria or a family history
4. Patients with synchronous colonic or rectal cancer (but not benign polyps)
5. Patients with coexistent inflammatory bowel disease, such as Crohn’s disease, ulcerative colitis or active diverticulitis, which may influence the lymphatic uptake of 5-ALA
6. Pregnant (positive pregnancy test) or breast feeding. 5-ALA has unknown teratogenic and abortifacient effects.
7. Received an investigational medicinal product at any dose within 28 days before registration
8. Poorly controlled or serious medical or psychiatric illness that, in the Investigator’s opinion, is likely to interfere with participation and/or compliance in this clinical trial.

Recruitment start date

01/06/2013

Recruitment end date

30/11/2014

Locations

Countries of recruitment

Ireland, United Kingdom

Trial participating centre

University of Leeds & Leeds Teaching Hospitals NHS Trust
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

c/o Neville Young
34 Hyde Terrace
Leeds
LS2 9LN
United Kingdom

Sponsor type

University/education

Website

http://www.leeds.ac.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) - Efficacy and Mechanism Evaluation Programme (Grant Ref: 11/100/24)

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

Publication citations

Additional files

Editorial Notes