drugset / Trial / NCT03205501

Molecular Fluorescence Endoscopy of (Pre)Malignant Esophageal Lesions

NCT03205501 ↗

Phase 1 Completed 15 enrolled University Medical Center Groningen
NaSingle-groupOpen-labelDiagnostic

Summary

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.

Timeline

Start
2017-02-09
Primary completion
2019-03-25
Completion
2019-09-01

Drugs

EvaluationDrugModalityDoseRoute
Subject EMI-137 Peptide 0.13 mg/kg Intravenous