Molecular Fluorescence Endoscopy of (Pre)Malignant Esophageal Lesions (EAGLE)
To improve detection of esophageal (pre)malignant lesions during surveillance endoscopy of patients at risk of developing malignancies, for example in Barrett's Esophagus (BE), there is a need for better endoscopic visualization and the ability for targeted biopsies. Optical molecular imaging of neoplasia associated biomarkers could form a promising technique to accommodate this need. It is known that the biomarker c-Met is overexpressed in dysplastic and neoplastic areas in BE segments versus normal tissue and has proven to be a valid target for molecular imaging.
Edinburgh Molecular Imaging Ltd (EMI) has developed a fluorescent tracer specifically targeting c-Met by labeling a small peptide to a fluorescent fluorophore: 'EMI-137'. The investigators hypothesize that when EMI-137 is administered intravenously, it accumulates in c-Met expressing high grade dysplasia (HGD) and esophageal adenocarcinoma (EAC), enabling (early) cancer visualization using a newly developed fluorescent fiber-bundle. This hypothesis will be tested in the current pilot intervention study.
|Barrett Esophagus Esophageal Cancer Dysplasia in Barrett Esophagus||Drug: IV-administation of EMI-137 Device: Molecular Fluorescence Endoscopy platform||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
|Official 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|
- Tumor-to-background ratio that allows the in vivo detection of (pre)malignant lesions in patients with Barrett's Esophagus using molecular fluorescence endoscopy. [ Time Frame: Day 1 ]Calculation of the in vivo tumor-to-background ratio (> 1.5) based on fluorescence intensities in (pre)malignant lesions compared to surrounding healthy esophageal tissue.
- Safety: the number of participants with symptoms or changes in vital signs (blood pressure, heart frequency and temperature) and/or (serious) adverse events that are related to administration of EMI-137. [ Time Frame: Up to day 3 ]
- The correlation of fluorescence signals to histopathology from (pre)malignant lesions and surrounding normal esophageal tissue. [ Time Frame: Up to 1 year ]
- Identification of fluorescence lesions and correlation with histopathology on subsequent biopsies in the resection surface after endoscopic mucosal resection. [ Time Frame: Up to 1 year ]
- Quantification of fluorescence signals in vivo and ex vivo of (pre)malignant lesions and normal esophageal tissue using multi-diameter single-fiber reflectance single-fiber fluorescence (MDSFR-SFF) spectroscopy. [ Time Frame: Up to 1 year ]
- Visualization of the localization and distribution patterns of EMI-137 in the esophagus using ex vivo fluorescence microscopy. [ Time Frame: Up to 1 year ]
|Actual Study Start Date:||February 1, 2017|
|Estimated Study Completion Date:||December 1, 2018|
|Estimated Primary Completion Date:||December 1, 2017 (Final data collection date for primary outcome measure)|
Experimental: IV-tracer EMI-137
Drug: IV-administation of EMI-137
Intravenous administration of 0.13 mg/kg of the fluorescent tracer EMI-137 approximately 2.5 hours prior to the endoscopy procedure.
Other Name: Tracer administationDevice: Molecular Fluorescence Endoscopy platform
A flexible fluorescence fiber-bundle is attached to a fluorescence camera platform to enable the detection of fluorescence signals. The fluorescence fiber-probe is inserted through the standard working-channel of the standard clinical endoscope. Fluorescence imaging will be performed prior to and post the endoscopic resection, during the same endoscopy procedure.
Other Name: Fluorescence Endoscopy
Please refer to this study by its ClinicalTrials.gov identifier: NCT03205501
|University Medical Center Groningen|
|Groningen, Netherlands, 9713GZ|
|Principal Investigator:||W.B. Nagengast, MD, PhD, PharmD||University Medical Center Groningen|
|Principal Investigator:||G.M. van Dam, MD, PhD||University Medical Center Groningen|