Abstract
Esophageal cancer (EC) is affecting more than 450,000 people worldwide and is the 6th leading cause of cancer-related deaths. The poor EC survival is attributed to the insufficient methods for premalignant lesion detection and therefore there is a great need for new endoscopic techniques that can visualize early stage lesions. In this phase II study we aim to evaluate the sensitivity and specificity of the tracer bevacizumab-800CW in combination with near infrared fluorescent molecular endoscopy (NIR-FME) for detecting (pre)malignant lesions in patients with Barrett’s esophagus (BE).
The tracer, Bevacizumab-800CW, was topically administered to the patients and after 5 minutes of incubation NIR-FME was performed. To quantify the intrinsic fluorescent signal, we used multi-diameter single fiber spectroscopy/single fiber fluorescence (MDSFR/SFF) spectroscopy measurements both in vivo and ex vivo. In case of additional fluorescent lesions biopsies were taken to analyze if dysplasia was present. The day after the endoscopic procedure the endoscopic mucosal resection (EMR) specimen was analyzed with widefield back-table imaging.
In our preliminary results topical-based NIR-FME detected all 4 adenocarcinoma lesions and all 8 high grade dysplasia lesions. Additionally, in one patient, this novel endoscopic technique identified another dysplastic lesion which was not visualized by high definition white light endoscopy (HD-WLE) and narrow band imaging (NBI) inspection. In our cohort no (serious) adverse events related to the tracer were observed. In the upcoming months we will include 52 more patients, add MDSFR/SFF spectroscopy data and determine tumor to background ratios.
Based on the preliminary results combined with the results of the Phase I study we can conclude that VEGF-A guided NIR-FME is able to reliably detect (pre)malignant dysplastic lesions in patients with BE and improves early lesion detection compared with HD-WL/NBI endoscopy. Moreover, the topically administered tracer Bevacizumab-800CW is safe and well tolerated.
The tracer, Bevacizumab-800CW, was topically administered to the patients and after 5 minutes of incubation NIR-FME was performed. To quantify the intrinsic fluorescent signal, we used multi-diameter single fiber spectroscopy/single fiber fluorescence (MDSFR/SFF) spectroscopy measurements both in vivo and ex vivo. In case of additional fluorescent lesions biopsies were taken to analyze if dysplasia was present. The day after the endoscopic procedure the endoscopic mucosal resection (EMR) specimen was analyzed with widefield back-table imaging.
In our preliminary results topical-based NIR-FME detected all 4 adenocarcinoma lesions and all 8 high grade dysplasia lesions. Additionally, in one patient, this novel endoscopic technique identified another dysplastic lesion which was not visualized by high definition white light endoscopy (HD-WLE) and narrow band imaging (NBI) inspection. In our cohort no (serious) adverse events related to the tracer were observed. In the upcoming months we will include 52 more patients, add MDSFR/SFF spectroscopy data and determine tumor to background ratios.
Based on the preliminary results combined with the results of the Phase I study we can conclude that VEGF-A guided NIR-FME is able to reliably detect (pre)malignant dysplastic lesions in patients with BE and improves early lesion detection compared with HD-WL/NBI endoscopy. Moreover, the topically administered tracer Bevacizumab-800CW is safe and well tolerated.
| Original language | English |
|---|---|
| Journal | Endoscopy |
| Publication status | Published - 24-Apr-2020 |