A study looking at a new fluorescent substance called EMI-137 to help doctors spot bowel cancer during surgery

Cancer type:

Bowel (colorectal) cancer
Colon cancer

Status:

Open
This study is for people with bowel cancer who are going to have surgery to remove part of the bowel. 
 
It is for people who are going to St James’ University Hospital.
 

More about this trial

Surgery is a possible treatment for bowel cancer. The type of surgery you have depends on where the cancer is and how far it has grown. 

During surgery, doctors try to remove all of the cancer and a border of healthy tissue around it. But it can be difficult for doctors to clearly see where the cancer is with their naked eye. This may lead to some of the cancer being left behind. 

In this study, doctors are using a new fluorescent substance called EMI-137. Doctors think that the EMI-137 can light up bowel cancer when they shine a special light onto the bowel. 

The main aim of this study is to find out whether the EMI-137 can light up the bowel cancer and any nearby lymph nodes that might contain cancer cells during surgery. This would help the surgeon make sure that they remove the cancer completely.

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you. 
 
Who can take part
You may be able to join this study if all of the following apply:
  • you have cancer of the large bowel (colon)
  • your kidneys and liver are working well
  • doctors think that you are well enough to have an anaesthetic Open a glossary item
  • you are at least 18 years old
  • you are willing to use reliable contraception for 3 months after surgery if there is any possibility that you or your partner could become pregnant
 
Who can’t take part
You cannot join this study if any of these apply. You:
  • have had, or are going to have, chemotherapy before surgery (neoadjuvant treatment Open a glossary item)
  • are taking part in another clinical trial that uses a fluorescence substance, or have had a fluorescence substance in the past 3 months
  • have had an investigational treatment in the last month
  • have bowel problems such as inflammatory bowel disease
  • are known to be sensitive to fluorescent substances
  • have any serious medical condition or mental health problem that the trial team think could affect you taking part
  • are pregnant or breastfeeding

Trial design

Researchers hope that around 10 people who are going to have surgery for bowel cancer will take part.

Between 2 and 3 hours before surgery, you have the EMI-137 as a drip into a vein. You then have the operation using a keyhole (laparoscopic) technique. This means that your surgeon makes small cuts into your tummy (abdomen). They pass a camera through one cut and put the surgical tools through the other cuts. 

During the operation, doctors use the camera to look for bowel cancer. They also shine a special light to find out if it helps to see the cancer more clearly. Doctors then try to remove all the cancer they find. 

The trial team might take pictures and make videos during the operation. This is so they learn as much as possible from this study. The videos and photographs are anonymised. So no one will be able to identify you. 

Hospital visits

You don’t have any extra hospital visits as part of this study. You have your surgery at St James’ University Hospital. 

You stay in hospital for about a week after surgery. Before you go home, your nurse gives you information about how to care for the wounds. 

About 3 weeks after the operation, you have a follow up appointment. This is the same as the standard treatment. During this appointment, the trial doctor will check how you are and see whether you have had any side effects from the EMI-137.

Side effects

EMI-137 is a new substance and has already been used in small studies in Europe. So, there might be side effects we don’t know about yet. 
 
The trial team monitor you during the time you have the EMI-137 and afterwards. You have a phone number to call them if you are worried about anything after you go home.
 
So far, the side effects of EMI-137 include:
 
an allergic reaction (this is usually mild)
changes to the colour of your skin around the drip site (this can last for a few hours)
changes to the colour of your urine for a few hours after surgery
 

Location

Leeds

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

The Leeds Teaching Hospitals NHS Trust
University of Leeds
EMI Ltd

 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

15471

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

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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