Barrett's Esophagus
Conditions
Interventions
Patients with a known BE-segment with dysplasia and patients with superficial
T1 EAC are referred to the UMCG to undergo a second diagnostic and/or
therapeutic endoscopy, according to standard clini
standard
clinical procedure when dysplasia is suspected) will be performed to obtain in
vivo histological information of the suspicious lesions with an adjusted
CLE-system for detection of fluoresc
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The safety of molecular fluorescence endoscopy using the fluorescent tracer EMI-137 (measurements of vital paramaters after injection, evaluation of side effects and possible (serious) adverse events). 2. The feasibility of molecular fluorescence endoscopy using the fluorescent tracer EMI-137 in order to detect (pre)malignant lesions in patients with Barrett's esophagus: - The accumulation of EMI-137 in (pre)malignant lesions in patients with Barrett's Esophagus and detection of fluorescence signals in (pre)malignant lesions on a macroscopic and microscopic level. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Extensive ex vivo analyses: the correlation of in vivo measured fluorescence with ex vivo histopathology (hematoxylin and eosin staining) and immunihistochimistry (e.g. c-Met staining). - the detection of fluorescence on a microscopic leven using fluorescence microscopy. - the in vivo quantification of fluorescence measured in the (pre)malignant lesions using MDSFR/SFF spectroscopy and ex vivo measurements of fluorescence for evaluation. - the detection and correlation of histological abnormalities using confocal laser endomicroscopy in vivo in fluorescence lesions. - the tumor-to-background ratio (TBR) of fluorescence lesions with the surrounding BE-segment and normal esophageal tissue. - the evaluation of resection surfaces after endoscopic treatment using molecular fluorescence endoscopy. | — |
Countries
Netherlands
Outcome results
None listed