Optical Coherence Tomography of the Gastrointestinal Tract (OCT)

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.

Official Title

Optical Coherence Tomography of the Gastrointestinal Tract.

Conditions

• Barrett’s Oesophagus With or Without Dysplasia
• Patients With Early Oesophageal or Gastric Cancer
• Patients With Intestinal Metaplasia of the Stomach

Study Type

Observational

Study Design

Case-Only, Prospective

 

 

Further Details

Study Start

June 2005

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and older
• Genders Eligible for Study: Both
• Accepts Healthy Volunteers: No
• 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.

Inclusion Criteria:

• Patients with known Barrett’s oesophagus with or without dysplasia, who are scheduled for surveillance endoscopy with biopsy or endoscopic mucosal resection (EMR).
• Patients with early oesophageal or gastric cancer who are undergoing confirmatory endoscopy with biopsy. These cancers must be limited to T1 N0 M0 (tumour invades submucosa with no lymph node involvement and no metastasis) according to the American Joint Committee on Cancer (AJC) Guidelines (1988 or later). Tumours may either be adenocarcinoma or squamous cell cancers. EUS and CT scanning will be required to confirm tumour staging. Tumours must be limited only to the mucosa or submucosa when examined by high frequency c-EUS. Any thickness of tumour 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.

Exclusion Criteria:

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

Total Enrolment

Contact Details

Kenneth J Chang, MD
University of California, Irvine

Location: 

Irvine Medical Center
University of California
Orange, California, United States, 92868