RecruitingPHASE3INTERVENTIONAL

Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer

This study is for people having surgery for bowel (colorectal) cancer. Surgeons usually look for cancer using normal 'white light' vision. This study is testing if a special dye, called SGM-101, can help them see the cancer and any places it might have spread, like in the tummy lining, even better. SGM-101 is an 'intraoperative imaging agent,' meaning it's used during the operation to highlight cancer cells. Researchers want to see if using this dye leads to better results for patients. It's a large study involving many hospitals, and some patients will receive the dye while others will have standard surgery, so the two approaches can be compared fairly.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Surgimab

Enrolment target

300

Start

17 Jun 2019

Estimated completion

01 Dec 2024

Colorectal Neoplasms

What is this study about?

When someone has surgery for bowel cancer, the surgeon's main goal is to remove all the cancer they can see. This study is looking at a new tool that might help surgeons do an even better job. This tool is a special liquid, called SGM-101, which is injected into the patient before surgery. It's designed to make cancer cells 'light up' or become more visible during the operation.

Currently, surgeons use their eyes, often with special lights, to find and remove cancer. This is called 'white light' vision. The idea behind SGM-101 is that it attaches to cancer cells, making them stand out. This could help surgeons find cancer cells that are hard to see with normal vision, like small pieces of cancer or areas where it has spread.

In this study, some patients will receive the SGM-101 dye before their surgery, while others will have their surgery as normal. By comparing these two groups, doctors hope to understand if SGM-101 makes it easier for surgeons to find and remove all the cancer, and ultimately, if it can lead to better outcomes for patients with bowel cancer.

Key takeaways

This study is testing a new dye (SGM-101) to help surgeons see bowel cancer during operations.
It aims to find out if the dye helps surgeons remove cancer better than standard methods.
Participation involves either getting the dye or having standard surgery, decided by chance.
You must be scheduled for curative bowel cancer surgery to be eligible.
The study compares SGM-101 with the usual 'white light' way surgeons see.
This is a Phase 3 study, meaning it's in the later stages of testing new treatments or methods.

Who may be eligible?

This study is looking for adults aged 18 or older who are scheduled to have surgery for bowel (colorectal) cancer. This includes cancer that has grown deeply into the bowel wall, cancer that keeps coming back, or cancer that has spread to the lining of the tummy (peritoneum). It's important that this surgery is intended to cure the cancer.

For women, if you could still have children, you would need to have a negative pregnancy test on the day you receive the study injection. You would also need to agree to use effective birth control for 30 days before and 30 days after the injection. Women who can't get pregnant, for example, if they've had their tubes tied or are past menopause, can also take part.

There are also some reasons why you might not be able to join. For example, if you have other types of cancer (unless it's a very specific, treated skin or cervix cancer), or if you have certain problems with your liver, kidneys, or blood. People with serious infections or certain other health conditions, including HIV or hepatitis that isn't being treated, would also not be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you scheduled for surgery to remove bowel (colorectal) cancer that is meant to cure you?
Do you have primary, recurrent, or peritoneal bowel cancer?
Do you *not* have certain serious health problems affecting your liver, kidneys, or blood?
Are you *not* currently battling another type of cancer (except specific treated skin/cervix cancer)?
If you are a woman of child-bearing age, are you prepared to have a pregnancy test and use birth control?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you might receive an injection of the SGM-101 dye before your surgery, or you might have your surgery as usual, depending on how you are chosen by chance (like flipping a coin). During your surgery, the doctors will use special equipment to look for the dye. After your surgery, the doctors will continue to check your health in follow-up appointments, just as they would normally. The total duration of your participation will be discussed with you by the study team, but generally involves your scheduled surgery and follow-up care.

Potential risks and benefits

There is a chance that SGM-101 could help your surgeon find and remove more of your cancer, which might improve your recovery. However, like any medication, SGM-101 could have side effects, and your doctor will discuss these with you. There are also risks linked to any surgery. You are free to withdraw from the study at any time without affecting your usual medical care.

Locations (11)

City of Hope National Medical Center
Verified postcode
Duarte, United States· Recruiting
Moores Cancer Center - UCSD Health
Verified postcode
La Jolla, United States· Recruiting
Cleveland Clinic Florida
Verified postcode
Weston, United States· Recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Not yet recruiting
University of Massachusetts
Verified postcode
Worcester, United States· Recruiting
Perelman Center for Advanced Medicine
Verified postcode
Philadelphia, United States· Recruiting
Universitätsmedizin Göttingen, Klinik für Allgemein- Viszeral- und Kinderchirurgie
Verified postcode
Göttingen, Germany· Recruiting
Fondazione IRCCS Policlinico San Matteo
Verified postcode
Pavia, Italy· Recruiting
Catharina Ziekenhuis Eindhoven
Verified postcode
Eindhoven, Netherlands· Recruiting
Leiden University Medical Center
Verified postcode
Leiden, Netherlands· Recruiting
Erasmus MC
Verified postcode
Rotterdam, Netherlands· Recruiting

Common questions

What is SGM-101?

SGM-101 is a special dye that helps surgeons see bowel cancer cells more clearly during an operation.

Why is this study being done?

Doctors want to find out if using SGM-101 helps surgeons remove more cancer compared to regular surgery, potentially leading to better patient outcomes.

Will I definitely get the SGM-101 dye if I join?

Not necessarily. Patients are randomly chosen, like tossing a coin, to either receive the dye or have standard surgery, so the two approaches can be fairly compared.

Is SGM-101 a treatment for cancer?

No, SGM-101 is not a treatment. It's a tool used during surgery to help the surgeon find and remove the cancer more effectively.

How long will I be involved in the study?

Your involvement will cover the period around your surgery and any follow-up appointments, similar to your usual care. The exact length will be explained by the study team.

How to find out more

John Warner, JD, MPA

johna.warner@outlook.com 8123257657 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.