Molecular Fluorescence Endoscopy of (Pre)Malignant Esophageal Lesions (EAGLE)

University Medical Center Groningen (UMCG)

Status and phase: Completed; Phase 1

Conditions: Esophageal Cancer; Barrett Esophagus; Dysplasia in Barrett Esophagus

Treatments: Device: Molecular Fluorescence Endoscopy platform; Drug: IV-administation of EMI-137

Study type: Interventional

Funder types: Other

Identifiers

NCT03205501

NL59628.042.16

Details and patient eligibility

About

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.

Full description

See brief summary.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years, eligible for a diagnostic and/or therapeutic endoscopy;

• At least a suspicion of low grade dysplasia (LGD) based on a prior endoscopy;

• World Health Organization (WHO) performance score of 0-2;

• Written informed consent;

• Mentally competent person that is able and willing to comply with study procedures;

• For female subjects who are of childbearing potential, are premenopausal with intact reproductive organs or are less than 2 years post-menopausal:

  • A negative serum pregnancy test prior to receiving the tracer;
  • Willing to ensure that she or her partner uses effective contraception during the trial and for 3 months thereafter.

Exclusion criteria

• Pregnancy or breast feeding;
• Advanced stage EAC patient not suitable for endoscopic resection;
• Medical or psychiatric conditions that compromise the patient's ability to give informed consent;
• Concurrent anticancer therapy (chemotherapy, radiotherapy, vaccines, immunotherapy) delivered within the last three months prior to the start of the treatment
• The subject has been included previously in this study or has been injected with another investigational medicinal product within the past six months.
• History of myocardial infarction (MI), Transient Ischemic Attack (TIA), CerebroVascular Accident (CVA), pulmonary embolism, uncontrolled congestive heart failure (CHF), significant liver disease, unstable angina within 6 months prior to enrollment.
• The subject had any significant change in their regular prescription or non-prescription medication between 14 days and 1 day prior to Investigational Medicinal Product (IMP) administration. Occasional use of analgesics, such as non-steroid anti-inflammatory drugs and/or paracetamol, was permitted at the discretion of the investigator. Use of hormonal contraceptives is permitted.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

IV-tracer EMI-137

Experimental group

Description:

* 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.

Treatment:

Device: Molecular Fluorescence Endoscopy platform

Drug: IV-administation of EMI-137