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.
- Conditions
- Barrett's Esophagus1001799010017991
- Registration Number
- NL-OMON42946
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. The safety of molecular fluorescence endoscopy using the fluorescent tracer<br /><br>EMI-137 (measurements of vital paramaters after injection, evaluation of side<br /><br>effects and possible (serious) adverse events).<br /><br>2. The feasibility of molecular fluorescence endoscopy using the fluorescent<br /><br>tracer EMI-137 in order to detect (pre)malignant lesions in patients with<br /><br>Barrett's esophagus:<br /><br>- The accumulation of EMI-137 in (pre)malignant lesions in patients with<br /><br>Barrett's Esophagus and detection of fluorescence signals in (pre)malignant<br /><br>lesions on a macroscopic and microscopic level.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Extensive ex vivo analyses: the correlation of in vivo measured fluorescence<br /><br>with ex vivo histopathology (hematoxylin and eosin staining) and<br /><br>immunihistochimistry (e.g. c-Met staining).<br /><br>- the detection of fluorescence on a microscopic leven using fluorescence<br /><br>microscopy.<br /><br>- the in vivo quantification of fluorescence measured in the (pre)malignant<br /><br>lesions using MDSFR/SFF spectroscopy and ex vivo measurements of fluorescence<br /><br>for evaluation.<br /><br>- the detection and correlation of histological abnormalities using confocal<br /><br>laser endomicroscopy in vivo in fluorescence lesions.<br /><br>- the tumor-to-background ratio (TBR) of fluorescence lesions with the<br /><br>surrounding BE-segment and normal esophageal tissue.<br /><br>- the evaluation of resection surfaces after endoscopic treatment using<br /><br>molecular fluorescence endoscopy.</p><br>