Phase I – EAGLE-study
Title: Molecular Fluorescence Endoscopy for the Detection of (pre)Malignant Lesions in Barrett’s Esophagus using a Fluorescent Tracer EMI-137 Targeting c-Met: a Single-center Feasibility and Safety Study.
Study design: The current study is a non-randomized, non-blinded, prospective, single-center feasibility study. Patients with a suspicion of at least low-grade dysplasia (LGD), that are planned to undergo a second diagnostic and/or therapeutic endoscopy will receive an intravenous (IV) injection of the c-Met targeted fluorescent tracer EMI-137 approximately 2.5 hours before the start of the endoscopic procedure. The endoscopy and study procedure will be clustered in one session: first routine inspection with a high-definition white-light (HD WL) endoscope, followed by fluorescence inspection with a probe-based F2 multispectral camera system (SurgVision BV). Quantification of fluorescence signals will be performed in vivo and ex vivo with multi-diameter single fiber fluorescence single fiber spectroscopy (MDSFR-SFF) measurements of fluorescent lesions. Biopsies will be taken in order to correlate fluorescence signals to histology.
Objectives: The main objectives of this pilot study are to determine the safety and feasibility of molecular fluorescence endoscopy using the fluorescent tracer EMI-137 in order to detect dysplasia and/or malignant lesions in patients with BE.
Study population: A total of 20 patients to 25 patients with a suspicion of at least low grade dysplasia (LGD) in BE that are scheduled to undergo a second diagnostic or therapeutic endoscopy will be included.