NL-OMON42946
Completed
Not Applicable
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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Barrett's Esophagus
- Sponsor
- niversitair Medisch Centrum Groningen
- Enrollment
- 25
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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;
- •\- 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.
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), 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.
Outcomes
Primary Outcomes
Not specified
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