ML7710 for fluorescence imaging: Detection of colorectal polyps in humans using c-Met targeted fluorescent peptide

Customer Case

Research by: GE Healthcare is a manufacturer & distributor of diagnostic imaging agents and radiopharmaceuticals, R&D collaborations with Leiden University MC for early detection of colorectal tumors.

Modulight products: ML7710 series clinical laser system (635 nm, 3 W)

Laser use: Clinical single-wavelength laser device used for exciting novel fluorescence probe used to detect colorectal polyps.

Link to the study:

Dr. James Hardwick, Professor of gastroenterology & hepatology

Research topics: Professor Hardwick’s research has contributed to many key improvements in the detection and treatment of colorectal tumors and his group has published the findings in many top journals of the field. Research on colorectal cancer focuses on prognostic factors, tumor microenvironment, optimization of surgical techniques especially for elderly patients, intraoperative fluorescence imaging, and intracellular signaling associated with the use of statins.

Motivation for the study

Polyps are small growths on the inner lining of the colon or rectum, affecting around 1 in 4 people over the age of 50. Certain types of polyps may eventually become cancerous, and colon cancer prevention relies on colonoscopy using white light to detect and remove the polyps. However, small and flat polyps are difficult to detect and frequently missed with this technique. More precise methods to detect polyps before they progress to colorectal cancer are urgently needed.

GE Healthcare’s patented EMI-137 (previously known as GE-137) fluorescent probe has the potential to improve early detection of cancers including ovarian, esophageal, thyroid, bile duct, and lung cancer. EMI-137 is labeled with a modified Cy5 dye and binds selectively to c-Met tyrosine kinase, which is a polyp biomarker. This intraveneous agent might enable surgeons to remove polyps more precisely during surgery using fluorescence colonoscope in contrast to standard white light colonoscope. In this first-in-human pilot study, the use of GE-137 for improved polyp detection was evaluated in 15 patients at high risk of colorectal cancer.

 

Study setup

A high-power ML7710 series clinical laser at 635 nm (3W) was utilized in a fluorescence imaging setup. Modulight also provides flexible multi-wavelength light engines to enable detection of multiple fluorescent dyes.

The above schematic is a simplified version of the illumination set-up from the original research.

Fluorescence colonoscopy setup with Modulight clinical laser.

Picture from the original publication reproduced with permission from the contact author of the publication.

 

 

Results

A total of 101 polyps were detected using standard colonoscopy, and all of these polyps were also visible in fluorescence colonoscopy with GE-137. However, GE-137 enabled detection of 22 additional polyps (22% improvement over standard colonoscopy). These addiotional polyps were mostly small (<6 mm in diameter) and flat. GE-137 was well tolerated and safe.

Large polyps (marked with arrows) are clearly visible in both standard colonoscopy and fluorescence colonoscopy with GE-137.

Small polyps (marked with arrows) that have either low or no visibility in standard colonoscopy can be visualized in fluorescence colonoscopy with GE-137.

Above images from the original publication reproduced with permission from the contact author of the publication.

 

 

Conclusions:
The results of the pilot study demonstrate that fluorescence colonoscopy using GE-137 is feasible and safe. It enabled visualization of polyps that were missed in white light colonoscopy. Edinburgh Molecular Imaging has acquired exclusive global license for GE-137, now EMI-137, from GE Healthcare and is now further investigating its potential in clinical trials held in Netherlands & UK for colorectal, thyroid, and esophageal cancers.

 

 

Related Publications

Detection of colorectal polyps in humans using an intravenously administered fluorescent peptide targeted against c-Met
Jacobus Burggraaf, Ingrid M C Kamerling, Paul B Gordon, Lenneke Schrier, Marieke L de Kam, Andrea J Kales, Ragnar Bendiksen, Bård Indrevoll, Roger M Bjerke, Siver A Moestue, Siavash Yazdanfar, Alexandra M J Langers, Marit Swaerd-Nordmo, Geir Torheim, Madhuri V Warren, Hans Morreau, Philip W Voorneveld, Tessa Buckle, Fijs W B van Leeuwen, Liv-Ingrid Ødegårdstuen, Grethe T Dalsgaard, Andrew Healey & James C H Hardwick
Nature Medicine, 2015, 21 (8)

 

 

 

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