Assessing the safety and feasibility of optical coherence tomography and near-infrared fluorescence capsule endoscopy in Barrett’s Esophagus patients

Aims To improve lesion detection in Barret Esophagus (BE), better endoscopic visualization and targeted biopsies are needed. Fluorescence molecular endoscopy (FME) with a targeted tracer is promising [1] but lacks depth information limiting diagnostic yield. This study evaluates the safety and feasibility of a next-gen imaging system [2] [3], immuno-OCT, combining optical coherence tomography (OCT) and near-infrared fluorescence (NIRF). OCT will provide depth information and the NIRF will provide molecular information enabling detailed discrimination between healthy, inflamed, dysplastic, and tumorous tissue.

Methods This single-center interventional prospective trial, enrolling 15 patients undergoing an endoscopic resection, was approved by the Dutch medical ethics committee. Patients receive 25mg of Bevacizumab-800CW (fluorescent tracer targeting VEGF-A) intravenously 2-4 days before the procedure. The process has four phases; first, standard care with high definition white light endoscopy to identify visible lesions. Second, FME was applied including re-inspection of suspicious fluorescent areas with HD-WLE if applicable. Third, the immune-OCT capsule, attached to the endoscope, was used. Lastly, biopsies were taken for ex vivo comparison and the endoscopic resection was completed. Resected specimen was imaged using a Galvo scanner [4] and a fluorescence flatbed scanner directly after the procedure and post-formalin.

Results To date, three patients have been included, no device-related (serious) adverse events or technical issues were reported. Due to an abnormal anatomical variation the immuno-OCT capsule could not be inserted into the esophagus of one patient as a sharp and narrow turn obstructed access. Nevertheless, endoscopic resection and ex vivo imaging were successfully performed. Histological analysis revealed esophageal adenocarcinoma in two patients and low-grade to high-grade dysplasia in one.

Conclusions These preliminary findings show the safety and feasibility of imaging with the immuno-OCT device in BE patients. The insertion difficulties with the immuno-OCT attached to the endoscope were caused by anatomical abnormalities which may be overcome by using the capsule independently from the endoscope, its intended use. The results are not conclusive yet, however, the visual assessment shows the potential of the technique in discrimination between healthy and diseased tissue. A more robust conclusion on the safety and feasibility of the immuno-OCT capsule for acquisition in BE should be drawn after the inclusion of all participants. We will enlarge the cohort to 15 patients. Following the here described trial, further research can assess the standalone and first-line clinical use of this technique to identify BE lesions.

Publikationsverlauf

Artikel online veröffentlicht:
27. März 2025

• References

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