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. - Fluorescence endoscopy of (pre)malignant esophageal lesions.

niversitair Medisch Centrum Groningen0 个研究点目标入组 25 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

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

•- 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), TIA, 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 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.

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