Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal Adenocarcinoma

Sponsor

Anandasabapathy, Sharmila, M.D. (Other)

Overall Status

Recruiting

CT.gov ID

NCT02018367

Collaborator

William Marsh Rice University (Other), Baylor College of Medicine (Other)

100

Enrollment

Location

Arms

111

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The overall goal of the study is to determine whether imaging with the low-cost High Resolution Microendoscope(HRME) will increase the efficiency and yield of the current standard of endoscopic surveillance of Barrett's esophagus. We believe the HRME will provide an in-vivo "optical biopsy" that will be comparable to gold standard histopathology and allow the endoscopist to make a more informed decision about whether to obtain a biopsy or even perform endoscopic therapy (i.e. endoscopic mucosal resection, EMR).

Condition or Disease	Intervention/Treatment	Phase
Barrett's Esophagus	Drug: Proflavine, high resolution imaging	Phase 2

Detailed Description

Primary outcomes:

the diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRME with directed biopsy
compared to standard white-light endoscopy with 4-quadrant random biopsy (WL) for the diagnosis of BE-associated neoplasia in flat mucosa as well as mucosal lesions
the clinical impact of HRME on the diagnosis and endoscopic surveillance of BE- associated neoplasia
does HRME alter the decision to obtain a mucosal biopsy or perform endoscopic mucosal resection (EMR)
the total number of total mucosal biopsies taken per procedure; does HRME alter the number of biopsies necessary?

Secondary outcomes:

sensitivity, specificity, positive predictive value, and negative predictive value of HRME for the in-vivo diagnosis of neoplasia in a routine surveillance population of patients with BE (using histopathologic diagnosis of mucosal biopsies as the reference standard)
the total procedure time for imaging and mucosal biopsy acquisition of HRME - compared with WL, stratified by length of BE (< 3 cm and > 3cm)

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Accuracy, Yield and Clinical Impact of a Low-Cost High Resolution Microendoscope in the Early Diagnosis of Esophageal Adenocarcinoma

Study Start Date :

Sep 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Proflavine, high resolution imaging Proflavine hemisulfate will be used as a topical contrast agent in conjunction with the high resolution imaging device to visualize and image areas suspicious for neoplasia. Biopsies will be taken per Seattle biopsy protocol for Barrett's Esophagus surveillance.	Drug: Proflavine, high resolution imaging 5-10mL of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa. The HRME will then be inserted through the biopsy channel of the endoscope and gently placed against the mucosa. The endoscopist will image each discrete lesion observed during white light endoscopy. For each HRME imaged area, an optical read will be obtained followed by a tissue biopsy. Other Names: Proflavine hemisulfate
No Intervention: Standard of care Standard of care examination of the upper GI tract using the standard high resolution endoscope with bipsies taken per Seattle biopsy protocol for Barrett's Esophagus surveillance.

Arm

Intervention/Treatment

Experimental: Proflavine, high resolution imaging

Proflavine hemisulfate will be used as a topical contrast agent in conjunction with the high resolution imaging device to visualize and image areas suspicious for neoplasia. Biopsies will be taken per Seattle biopsy protocol for Barrett's Esophagus surveillance.

Drug: Proflavine, high resolution imaging

5-10mL of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa. The HRME will then be inserted through the biopsy channel of the endoscope and gently placed against the mucosa. The endoscopist will image each discrete lesion observed during white light endoscopy. For each HRME imaged area, an optical read will be obtained followed by a tissue biopsy.

Other Names:

Proflavine hemisulfate

No Intervention: Standard of care

Standard of care examination of the upper GI tract using the standard high resolution endoscope with bipsies taken per Seattle biopsy protocol for Barrett's Esophagus surveillance.

Outcome Measures

Primary Outcome Measures

The diagnostic yield (defined as the proportion of mucosal biopsy samples with neoplasia) of HRME with directed biopsy [1 day]
Compared to standard white-light endoscopy with 4-quadrant random biopsy (WL) for the diagnosis of BE-associated neoplasia in flat mucosa as well as mucosal lesions

Secondary Outcome Measures

The diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of HRME for the in-vivo diagnosis of neoplasia. [1 day]
To be determined using histopathologic diagnosis of mucosal biopsise as the reference standard

Other Outcome Measures

The clinical impact of HRME on the diagnosis and endoscopic surveillance of BE- associated neoplasia [1 day]
Does HRME alter the decision to obtain a mucosal biopsy or perform endoscopic mucosal resection (EMR) The total number of total mucosal biopsies taken per procedure; does HRME alter the number of biopsies necessary?

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

outpatients with > 1 cm biopsy-proven Barrett's Esophagus who are undergoing standard of care endoscopic surveillance for metaplasia, dysplasia, or neoplasia.

Exclusion Criteria:

Allergy or prior reaction to the fluorescent contrast agent proflavine
Patients who are unable to give informed consent.
Known advanced adenocarcinoma of the distal esophagus, or dysplastic/suspected malignant esophageal lesion > 2 cm in size not amenable to EMR
Patients with a history of a severe allergic reaction (anaphylaxis)
Patients unable to undergo routine endoscopy with biopsy :
Women who are pregnant or breastfeeding
Prothrombin Time > 50% of control; PTT > 50 sec, or INR > 2.0)
Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other
Patients with known, untreated esophageal strictures, prior partial esophageal resection, or altered anatomy preventing passage of the endomicroscope
Patients with known severe esophagitis
Patients with suspected but no biopsy confirmed BE