CompletedNot Applicable

Optical Coherence Tomography of the Gastrointestinal Tract

United States4 participantsStarted 2005-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 dilatio…

What they're measuring

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

Timeframe: 1 hour

Trial details

NCT IDNCT00579748

SponsorUniversity of California, Irvine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2007-11