Photoacoustic Endoscopy of Barrett's Esophagus

NCT02606292 | Completed Early Phase 1

• 1 other identifier: 201204145
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopy is an important technique in medicine to diagnose internal organs. Video endoscopy has been the most common technique providing clear, real time video images of organs' surfaces. However, this technique only images the surface and cannot effectively diagnose diseased tissues that develop in endothelial tissues. Endoscopic ultrasound (EUS) has been developed to overcome this limitation, and it is widely utilized in diagnosing GI diseases. This technique can image very deep areas of organs, up to several centimeters; however, it suffers from speckle artifacts and cannot adequately provide early diagnosis of tissue abnormalities that do not show mechanical properties that differ significantly from those of normal tissues. The investigators propose that photoacoustic endoscopy (PAE), an endoscopic embodiment of the rapidly growing photoacoustic tomography (PAT) technology, can fulfill the aforementioned need.

Conditions

Barrett Esophagus

Outcome Measures

Primary Outcomes (2)

• Feasibility of PA endoscopic imaging as an alternative real-time noninvasive tool for evaluation of Barrett's esophagus as measured by the agreement between the PA imaging system and the standard esophageal biopsy for diagnosing Barrett's epithelium

  -The investigators will image a series of human esophagi in patients with an established diagnosis of Barrett's esophagus with/without dysplasia to fine-tune the PA imaging system. The investigators will assess the agreement between the PA imaging system and the standard clinical practice of four-quadrant esophageal biopsy previously performed in this cohort of patients as part of his/her active surveillance program.

  Day 1

• Sensitivity and specificity of PA endoscopic imaging for identification of Barrett's epithelium compared to esophageal biopsy

  -The investigators will image a series of human esophagi in patients with an established diagnosis of Barrett's esophagus with/without dysplasia to fine-tune the PA imaging system. The investigators will assess the agreement between the PA imaging system and the standard clinical practice of four-quadrant esophageal biopsy previously performed in this cohort of patients as part of his/her active surveillance program.

  Day 1

Study Arms (1)

Arm 1: PAE assessment

EXPERIMENTAL

-The PAE-EUS assessment will be performed in the operating room by the after induction of general anesthesia and following strict sterile technique while the patient is being positioned and prepped for esophageal surgery.

Procedure: Photoacoustic endoscopy; Procedure: Endoscopic ultrasound (standard of care); Procedure: Endoscopic surgery (standard of care)

Interventions

Photoacoustic endoscopy PROCEDURE

Also known as: PAE

Arm 1: PAE assessment

Endoscopic ultrasound (standard of care) PROCEDURE

Also known as: EUS

Arm 1: PAE assessment

Endoscopic surgery (standard of care) PROCEDURE

Arm 1: PAE assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years and older.
• Patients with Barrett's esophagus scheduled for esophageal surgery.
• Patients with GERD, but without Barrett's esophagus, scheduled for esophageal surgery.
• Subjects must be able to understand and willing to sign a written informed consent form.

You may not qualify if:

• Inability to give informed consent.
• Pregnancy.
• Age less than 18 years
• Previous esophageal procedure (surgery, photodynamic therapy, argon plasma coagulation, endoscopic mucosal resection).
• Acute GI bleeding.
• Coagulopathy.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Standard of Care; Endoscopy

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Bryan F Meyers, M.D., M.P.H.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2015
• First Posted: November 17, 2015
• Study Start: August 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

US (1)