Optical Coherence Tomography of the Gastrointestinal Tract

NCT00579748 | Completed DMC

• 3 other identifiers: HS# 2005-4314Award Number: CA-91717Proposal Number: 30011
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Optical coherence tomography (OCT) is a non-invasive imaging technique that uses light to create pictures of living tissues and has been successfully used to generate high resolution cross-sectional images of tissue in the human eye and skin. OCT systems are now commercially available for eye and skin use, and several clinical reports on the use of OCT in the gastrointestinal tract have been published as well. The purpose of this study is to develop a high-speed noninvasive OCT probe which can be placed through an endoscope for the early diagnosis of pre-cancerous and cancerous lesions in the gastrointestinal tract. This is a pilot clinical research study that is designed to advance OCT technology, which may in the future be able to replace or augment endoscopic biopsies.

Conditions

Barrett's Esophagus With or Without Dysplasia; Patients With Early Esophageal or Gastric Cancer; Patients With Intestinal Metaplasia of the Stomach

Keywords

OCT imaging; Barrett's esophagus

Outcome Measures

Primary Outcomes (1)

• The OCT images will be correlated to the specific biopsy site and biopsy number.

  1 hour

Study Arms (1)

1

Eligibility Criteria

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

Study Population

This study will involve the OCT imaging of patients undergoing endoscopy of the upper digestive tract in the gastrointestinal endoscopy suite in the H. H. Chao Digestive Diseases Center (CDDC) at UC Irvine Medical Center. These patients will include: 1) patients with known Barrett's esophagus with or without dysplasia, who are scheduled for surveillance endoscopy with biopsy or endoscopic mucosal resection (EMR) 2) patients with early esophageal or gastric cancer who are undergoing confirmatory endoscopy with biopsy or 3) patients with intestinal metaplasia with or without dysplasia of the stomach who are undergoing endoscopy with biopsy or EMR.

You may qualify if:

• Patients with known Barrett's esophagus with or without dysplasia, who are scheduled for surveillance endoscopy with biopsy or endoscopic mucosal resection (EMR).
• Patients with early esophageal or gastric cancer who are undergoing confirmatory endoscopy with biopsy. These cancers must be limited to T1 N0 M0 (tumor invades submucosa with no lymph node involvement and no metastasis) according to the American Joint Committee on Cancer (AJC) Guidelines (1988 or later). Tumors may either be adenocarcinoma or squamous cell cancers. EUS and CT scanning will be required to confirm tumor staging. Tumors must be limited only to the mucosa or submucosa when examined by high frequency c-EUS. Any thickness of tumor lesion is acceptable provided the lesion does not appear to reach the muscularis propria.
• Patients with intestinal metaplasia with or without dysplasia of the stomach who are undergoing endoscopy with biopsy or EMR.
• Patients must be at least 18 years of age. Female patients must not be pregnant (must have a negative serum pregnancy test) or nursing, and must be practicing a medically acceptable form of birth control or be sterile or postmenopausal.
• Patients must sign an informed consent.

You may not qualify if:

• Patients with esophageal or gastric cancer, who have tumor extension into the muscularis propria on endoscopic ultrasonography (EUS) (i.e. tumor depth of invasion T2 or greater).
• Patients with esophageal strictures unresponsive to dilation.
• Patients with known contraindications to analgesia or endoscopy.
• Patients with inability to understand or carry out instructions.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

pinch biopsies blood

MeSH Terms

Conditions

Stomach Neoplasms; Barrett Esophagus

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Precancerous Conditions; Esophageal Diseases

Study Officials

• Kenneth J Chang, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

• Zhongping Chen, Ph.D.

  University of California, Irvine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 24, 2007
• Study Start: June 1, 2005
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: April 9, 2021

Record last verified: 2021-04

Locations

US (1)