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Optical Coherence Tomography (OCT) Based Screening of Esophagus and Gastroesophageal Junction

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Guillermo Tearney, Massachusetts General Hospital Identifier:
First received: July 20, 2011
Last updated: April 14, 2016
Last verified: April 2016
The specific aim of this study is to determine the accuracy of Optical Coherence Tomography (OCT) imaging for screening and diagnosis of the distal esophagus in patients undergoing a clinical esophagogastroduodenoscopy (EGD) procedure. The accuracy of results obtained using the developed OCT imaging probe will be determined and compared with those obtained through the traditional standard of care endoscopic biopsy .

Condition Intervention Phase
Barrett's Esophagus
Device: Optical Frequency Domain Imaging (OFDI) System
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Optical Coherence Tomography Based Screening and Surveillance of Esophagus and Gastroesophageal Junction

Resource links provided by NLM:

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Sensitivity and specificity of OFDI imaging [ Time Frame: Images will be acquired during the OFDI imaging session which should take an average of 5 minutes ] [ Designated as safety issue: No ]
    Images will be analyzed and compared to standard of care biopsy

Enrollment: 110
Study Start Date: September 2006
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Optical Frequency Domain imaging System
OFDI imaging
Device: Optical Frequency Domain Imaging (OFDI) System
OFDI Imaging of esophagus

Detailed Description:

Three hundred consenting patients undergoing routine esophagogastroduodenoscopy (EGD) procedures will be recruited for examination at the gastroesophageal junction with our developed OCT imaging system. The patients will undergo a clinical EGD procedure including endoscopic biopsy. The first step in the procedure follows the standard care with the performance of the surveillance endoscopy. The study experimental procedure will then begin. This study requires the use of a balloon . The balloon placement method is in accordance with current standard clinical practice and involves the insertion of a guide wire through the auxiliary channel of the endoscope. The endoscope is then removed, leaving the guide wire in place, and the OCT balloon is inserted the required distance (determined during the endoscopy) over the guide wire to the GE junction. The OCT balloon will then be inflated and will remain in this fixed position throughout the entire procedure. Once the OCT imaging probe is in place, OCT image data will be continuously collected over the length of the balloon(approximately 5 cm).

It is expected that the total examination time including insertion and inflation of the OCT balloon, OCT imaging and removal of the OCT balloon will add no more than 10 minutes to the total length of the EGD.


Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • over the age of 18,
  • capable of giving informed consent,
  • are undergoing elective EGD, and
  • if female are willing to take a pregnancy test

Exclusion Criteria:

  • patients on oral anticoagulation medications,
  • with a history of hemostasis disorders and
  • patients that are pregnant
  Contacts and Locations
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Please refer to this study by its identifier: NCT01401699

United States, Massachusetts
Massachussetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
Principal Investigator: Guillermo Tearney, MD PhD Massachussetts General Hospital
Principal Investigator: Norman Nishioka, MD Massachussetts General Hospital
  More Information

Responsible Party: Guillermo Tearney, Professor of Pathology, Massachusetts General Hospital Identifier: NCT01401699     History of Changes
Other Study ID Numbers: 2006-P-000203  5R21CA141884 
Study First Received: July 20, 2011
Last Updated: April 14, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases processed this record on October 21, 2016