University Medical Centre Groningen
Groningen, Provincie Groningen, 9713GZ, Netherlands
Location status: Recruiting
NCT Number: NCT07108855
Endoscopic submucosal dissection (ESD) is a relatively new technique to treat superficial cancers in the upper gastrointestinal (GI) tract. Previous studies reported high en bloc resection rates (95%-97%). However, R0 resection rates (84.5%) suggest that the tumour is not radically removed in all cases, resulting in a risk of tumour recurrence. One of the key challenges is the limited accuracy in determining the depth of cancer invasion. To reduce the risk of tumour recurrence, the endoscopist would greatly benefit from proper and complete visualization of the tumour margin and depth during ESD. Several studies have shown that near-infrared quantified fluorescence molecular endoscopy (qFME) could serve as a red flag detection method and might be a useful imaging tool for tumour demarcation in the upper GI tract. The aim of this study is to evaluate the feasibility of ICG-enhanced near-infrared qFME to determine tumour demarcation and tumour depth in upper GI tumours (e.g. superficial esophageal and/or gastric adenocarcinoma (T1)) during ESD.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Groningen, Provincie Groningen, 9713GZ, Netherlands
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(contraindications for indocyanine green):
Systemic administration of indocyanine green during the endoscopic procedure.
Near-infrared quantified fluorescence molecular endoscopy (qFME) will be used during the endoscopic procedure.
Time frame: One week after the qFME procedure
Feasibility will be assessed by analyzing the fluorescent imaging data obtained during and after the procedure. Visible fluorescence will be determined by calculating the target-to-background ratio (TBR), where the target is defined as the mean pixel intensity of the resection bed in areas displaying fluorescence.
Time frame: One week after the qFME procedure
Secondary evaluation will focus on whether visible fluorescence after resection correlates with an R1 resection grade based on histopathology.
Time frame: After study completion, to be expected within 8 months
Fluorescence will also be quantified using mucosal multi-diameter single-fiber reflectance / single-fiber fluorescence (MDSFR/SFF) spectroscopy, a non-invasive measurement technique.
Time frame: One week after the qFME procedure
Visibility is determined visual evaluation during the endoscopic procedure and calculating the TBR in the same manner as explained above.
Contact information is provided by the study sponsor or research team.
University Medical Center Groningen
Other
Detection of Upper Gastrointestinal Tumour Depth and Demarcation by Quantified Fluorescence Molecular Endoscopy Using Systemic Administration of Indocyanine Green During Endoscopic Submucosal Dissection
Acronym: BRIGHT
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