Molecular Fluorescence Endoscopy of (Pre)Malignant Esophageal Lesions

See brief summary.

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.