Selection of patients with early rectal cancer, T1 rectal cancer (T1RC) or high-grade
dysplasia (HGD), for local resection is based on endoscopic imaging, endorectal ultrasound
and/or MRI. However, all these imaging modalities have their limitations in the accurate
detection of small areas of cancer in large rectal polyps. Fluorescent guided endoscopy may
offer the opportunity to aid in detecting these small cancerous areas in colorectal polyps.
Detection of T1RC or HGD in large rectal polyps is essential to select patients for the
appropriate (endoscopic) resection technique. Completely benign polyps, solely containing
low-grade dysplasia (LGD), could be resected by piecemeal endoscopic mucosal resection
(pEMR), a fast technique on which almost all endoscopists are trained. However, for rectal
polyps with T1RC or HGD, curative resection must be achieved by en-bloc resection techniques
such as endoscopic submucosal dissection (ESD) or endoscopic intermuscular dissection (EID).
These techniques are more complex and expensive and only a small number of endoscopists are
trained on these techniques. pEMR of lesions with HGD or T1RC must be avoided because they
may result in irradical resections (R1) or in inconclusive histological margin assessment
since the polyp is not resected en-bloc. Often, this leads to unnecessary additional
abdominal surgical resections.
Furthermore reported sensitivities for optical diagnosis of T1RC in a polyp are low, varying
from 20.8% to 77.8%. Because of the limited accuracy of optical diagnosis, the current Dutch
guideline suggest that rectal polyps >3cm should be resected in an en-bloc manner, although
it has been demonstrated that only 10.2% of rectal polyps >3cm contain a malignant component.
Similarly, in recent studies it was shown that 10-15% of entirely benign polyps were removed
by abdominal surgery rather than endoscopically. This has major implications for the patient
since surgical resection is associated with considerable morbidity. Therefore, there is a
need of a technique that provide the endoscopist with real-time information about specific
molecular features of the tumor to differentiate between benign polyps with LGD amenable for
pEMR and those that contain HGD or T1RC that require en-bloc resection. Tumor targeted
fluorescence-guided surgery (FGS) has emerged as a technique with the potential to enable
real-time lesion visualization based on specific molecular features rather than on
morphology. Recently it was shown that carcinoembryonic antigen (CEA) is overexpressed in
approximately 75% of T1RC/HGD. Additionally, expression in LGD was (nearly) absent in 66% of
low-grade dysplastic tissue and in 98% of normal rectum tissue, making it a suitable marker
for distinguishing T1RC and HGD from LGD and normal tissue. CEA can be targeted by SGM-101,
an anti-CEA antibody attached to a fluorophore which has been studied in several clinical
studies for patients with colorectal cancer undergoing surgery. The investigators hypothesize
that the use of SGM-101 during endoscopy aids the endoscopist in discriminating benign polyps
with solely LGD from polyps containing T1RC/HGD.