A study of 5-ALA in bowel cancer surgery (GLiSten)

Cancer type:

Bowel (colorectal) cancer
Colon cancer

Status:

Results

Phase:

Other

This study was done to see if a substance called 5-ALA and a special light could help surgeons see lymph nodes that contain bowel cancer cells.

More about this trial

The most common place for bowel cancer to spread is the lymph nodes. When people have surgery to remove bowel cancer, the surgeon also removes some of the lymph nodes to check whether they contain cancer cells or not. It is important to know, as it can affect the treatment a person needs.
 
In this study, researchers used a substance called 5-ALA which can make cancer cells glow under a blue light. 
 
When this study was done, surgeons had used 5-ALA to help diagnose other cancers. But they hadn’t used it for bowel cancer before.
 
The people taking part in this study had a drink containing 5-ALA a few hours before their operation. They then had keyhole surgery to remove their bowel cancer. 
 
The surgeons looked at the lymph nodes under a special light to see if they glowed. They then removed the lymph nodes as usual, which were analysed in the laboratory to see if they contained cancer cells.
 
The aim of the study was to find the best dose of 5-ALA that will make bowel cancer cells glow under the blue light during surgery.

Summary of results

The study team found that 5-ALA did not make it easier to identify lymph nodes that contained bowel cancer cells.
 
This trial was open for people to join between 2013 and 2015, and the study team published the results in 2016.
 
About this study
There were 2 groups in this study. One had a lower dose of 5-ALA, and the other had a higher dose. Everyone taking part had bowel cancer and was due to have surgery. 
 
40 people took part is this study:
  • 17 had the lower dose of 5-ALA
  • 23 had the higher dose of 5-ALA
Results for people who had the lower dose
Of the 17 people who had the lower dose, 3 people had lymph nodes which glowed under the special light during surgery. But laboratory analysis showed that only 1 of these contained cancer cells. The other 2 didn’t contain cancer cells.
 
The research team analysed all the lymph nodes in the lab. The results showed that 9 people had cancer cells in their lymph nodes. But only 1 of these had glowed under the light during surgery. The other 8 looked like normal lymph nodes under the special light.
 
Results for people who had the higher dose
Of the 23 people who had the higher dose, 4 people had lymph nodes which glowed under the special light during surgery. But laboratory analysis showed that none of these contained cancer cells.
 
The research team analysed all the lymph nodes in the lab. The results showed that 7 people had cancer cells in their lymph nodes. But none of these had glowed under the light during surgery. All 7 looked like normal lymph nodes under the special light.
 
Side effects
5-ALA caused very few side effects:
  • 2 people were slightly more sensitive to light than usual for a few days
  • 4 people had a short term rise in a one of the enzymes found in the liver
Conclusion
The research team concluded that 5-ALA was not useful for identifying lymph nodes that contained bowel cancer cells. They cannot recommend that 5-ALA is used as part of assessment and diagnosis for people with bowel cancer.
 
Sometimes studies show that something doesn’t work as well as we’d hoped. But all results are useful. They add to our knowledge and understanding of cancer and how to treat it.
 
Where this information comes from
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor David Jayne

Supported by

NIHR Clinical Research Network: Cancer
NIHR Efficacy and Mechanism Evaluation (EME) Programme
St James's University Hospital
University of Leeds

 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

10821

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

Last reviewed:

Rate this page:

Currently rated: 3.3 out of 5 based on 4 votes
Thank you!
We've recently made some changes to the site, tell us what you think