NCT03205501: EAGLE

Molecular Fluorescence Endoscopy of (Pre)Malignant Esophageal Lesions

Completed Phase 1 Last updated 16 April 2024

What this trial tests

Phase 1 trial testing IV-administation of EMI-137 in Barrett Esophagus in 15 participants. Completed in 1 September 2019.

Timeline

9 February 2017

Primary endpoint
25 March 2019

1 September 2019

Quick facts

Lead sponsor	University Medical Center Groningen
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	15
Start date	9 February 2017
Primary completion	25 March 2019
Estimated completion	1 September 2019
Sites	1 location across Netherlands

Drugs / interventions tested

• IV-administation of EMI-137 — full drug profile →
• Molecular Fluorescence Endoscopy platform

Conditions studied

• Barrett Esophagus — all drugs for Barrett Esophagus →
• Esophageal Cancer — all drugs for Esophageal Cancer →
• Dysplasia in Barrett Esophagus — all drugs for Dysplasia in Barrett Esophagus →

Sponsor

University Medical Center Groningen

Who can join

18 and older, any sex, with Barrett Esophagus or Esophageal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Fluorescence Image-Guided Surgery - a Perspective on Contrast Agent Development.
   Barth CW, Gibbs SL. · · 2020 · cited 79× · PMID 32255887 · DOI 10.1117/12.2545292
2. Fluorescent Probes for Imaging in Humans: Where Are We Now?
   Seah D, Cheng Z, Vendrell M. · · 2023 · cited 65× · PMID 37787658 · DOI 10.1021/acsnano.3c03564
3. Targeted Optical Imaging Agents in Cancer: Focus on Clinical Applications.
   Joshi BP, Wang TD. · · 2018 · cited 63× · PMID 30224903 · DOI 10.1155/2018/2015237
4. C-Met targeted fluorescence molecular endoscopy in Barrett's esophagus patients and identification of outcome parameters for phase-I studies.
   de Jongh SJ, Voskuil FJ, Schmidt I, Karrenbeld A, et al · · 2020 · cited 28× · PMID 32373217 · DOI 10.7150/thno.42224
5. Fluorescent-guided surgery for sentinel lymph node detection in gastric cancer and carcinoembryonic antigen targeted fluorescent-guided surgery in colorectal and pancreatic cancer.
   Vuijk FA, Hilling DE, Mieog JSD, Vahrmeijer AL. · · 2018 · cited 26× · PMID 30216455 · DOI 10.1002/jso.25139
6. Advantages of patient-derived orthotopic mouse models and genetic reporters for developing fluorescence-guided surgery.
   Lwin TM, Hoffman RM, Bouvet M. · · 2018 · cited 25× · PMID 30080930 · DOI 10.1002/jso.25150
7. Detection by fluorescence of pituitary neuroendocrine tumour (PitNET) tissue during endoscopic transsphenoidal surgery using bevacizumab-800CW (DEPARTURE trial): study protocol for a non-randomised, non-blinded, single centre, feasibility and dose-finding trial.
   Vergeer RA, Postma MR, Schmidt I, Korsten-Meijer AG, et al · · 2021 · cited 6× · PMID 34620658 · DOI 10.1136/bmjopen-2021-049109
8. Transforming Cancer Diagnosis and Therapy Through Fluorescent Hydrogels: A Review.
   Masaeli E, Srinivasan S, Rajabzadeh AR. · · 2026 · cited 1× · PMID 40905474 · DOI 10.1002/adhm.202502577