Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Barrett Esophagus

Gastrointestinal Diseases

Esophageal Diseases

Precancerous Conditions

Esophageal Cancer

* IV-administration of EMI-137: all patients will receive 0.13 mg/kg of the fluorescent tracer EMI-137 intravenously.
* Molecular Fluorescence Endoscopy: approximately 2,5 hours after tracer administration, Molecular Fluorescence Endoscopy will be performed with additional measurements of fluorescence signals.

Intravenous administration of 0.13 mg/kg of the fluorescent tracer EMI-137 approximately 2.5 hours prior to the endoscopy procedure.

IV-administation of EMI-137

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.

Molecular Fluorescence Endoscopy platform

W.B. Nagengast, MD, PhD, PharmD

G.M. van Dam, MD, PhD

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.

Molecular Fluorescence Endoscopy of (Pre)Malignant Esophageal Lesions

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

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Molecular Fluorescence Endoscopy of (Pre)Malignant Esophageal Lesions	NCT03205501	Barrett Esophag... Esophageal Canc... Dysplasia in Ba...	IV-administatio... Molecular Fluor...	18 Years -	University Medical Center Groningen
Molecular Fluorescence Endoscopy of (Pre)Malignant Esophageal Lesions	NCT03205501	Barrett Esophag... Esophageal Canc... Dysplasia in Ba...	IV-administatio... Molecular Fluor...	18 Years -	University Medical Center Groningen
Molecular Fluorescence Endoscopy of (Pre)Malignant Esophageal Lesions	NCT03205501	Barrett Esophag... Esophageal Canc... Dysplasia in Ba...	IV-administatio... Molecular Fluor...	18 Years -	University Medical Center Groningen

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