Intramucosal Adenocarcinoma Clinical Trial
Barrett's esophagus (BE) is a pre-neoplastic condition formed by the metaplasia of the
normal squamous mucosa of the distal esophagus into a specialized intestinal mucosa. Its
development is mostly associated with chronic injury from gastroesophageal reflux. BE is
widely considered the leading risk factor for the development of esophageal adenocarcinoma
(EAC).
Volumetric laser endomicroscopy (VLE) can be thought of as an analogous technique to
ultrasound, however, instead of producing an image from the scattering of sound waves, it
utilizes optical scattering based on differences in tissue composition to form a
two-dimensional image. The benefit of VLE over ultrasound is that it is capable of
generating cross-sectional images of tissues with an axial-resolution of up to 10
micrometers, which is comparable to low-power microscopy.
The proposed trial will evaluate the ability of physicians to use VLE to visualize high
grade intraepithelial neoplasia (HGIN) or intramucosal adenocarcinoma (IMC) in both the
ex-vivo and in-vivo setting and correlate those images to standard histology of endoscopic
mucosal resection specimens as the gold standard.
The diagnosis of dysplasia and early adenocarcinoma in BE remains challenging. At present, endoscopy with biopsy of suspected BE lesions is the only available method. However, the endoscopic recognition of early dysplasia in BE relies on the subjective visual recognition by an endoscopist. The subtle mucosal variations and early dysplastic changes in the esophagus may easily be missed. The development of a wide-field, high resolution endoscopic microscopy could enhance the early detection and treatment of dysplasia in BE. ;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01787864 -
Prevalence of Dysplasia of the Gastric Cardia
|
N/A | |
| Enrolling by invitation |
NCT02427269 -
University of North Carolina (UNC) Barrett's Esophagus and Esophageal Cancer Biorepository
|
||
| Completed |
NCT04316975 -
Utility Of Mutational Load As A Predictor For Endoscopic Treatment Response In Barrett's Esophagus
|
N/A |