The University Medical Center started a new clinical trial of fluorescence molecular endoscopy in locally advanced Rectal Cancer
Photo by Artur Tumasjan
The University Medical Center Groningen is enrolling patients into the clinical trial investigating of Fluorescence Molecular Endoscopy and Molecular Fluorescence-guided Surgery in Locally Advanced Rectal Cancer (TRACT-II).
Treatment of patients with locally advanced rectal cancer (LARC) consists of neoadjuvant chemoradiotherapy (nCRT) followed by surgical removal of the rectal tumor and potentially tumor positive lymph nodes.
After surgery, in 15 to 27% of patients that received nCRT no tumor cells can be detected during histopathological examination. In today's clinical practice, all of these patients with a pathological complete response (pCR) are operated upon, with substantial morbidity and mortality. However, as MRI cannot differentiate between molecular characteristics of tissue, prediction of treatment response can be inaccurate. In patients with a potential cCR on MRI, additionally a high-definition white-light (HD-WL) endoscopy is performed with biopsies of the previous tumor location. If both MRI and HD-WL endoscopy confirm a potential cCR, patients can also be treated with a watch-and-wait approach, including frequent follow-up with HD-WL endoscopy and MRI. This potentially prevents extensive surgical procedures for patients in which this is not required. However, MRI and HD-WL endoscopy often remain insufficient for identification of cCR. Therefore, novel imaging methods are needed for accurate prediction of treatment response in order to select patients. The investigators believe fluorescence molecular endoscopy (FME) could be a promising technique for evaluation of treatment response.
During surgery, tumor-negative resection margins are of great prognostic value. Currently, surgeons rely on visual and tactile inspection for differentiation between malignant and healthy tissue. There is a need for novel imaging techniques that can be used intraoperatively to improve margin assessment. The investigators believe molecular fluorescence-guided surgery (MFGS) could be a promising technique for evaluation of resection margins.
The study start date is November 13, 2020.
The trial is designed to enroll the patients with locally advanced rectal cancer and clinical suspicion of residual tumor after neoadjuvant chemoradiotherapy and is being conducted in the University Medical Center Groningen, Groningen, Netherlands.
The University Medical Center Groningen (UMCG, Universitair Medisch Centrum Groningen), formerly Groningen University Hospital, is the main hospital in Groningen, Netherlands.
The medical centre is affiliated with the University of Groningen and offers supraregional tertiary care to the northern part of the Netherlands. Organ transplant operations of all possible kinds are carried out at the UMCG, including combined transplants of multiple organs in one operation.
This page provides a more detailed overview of this clinical trial:
