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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01401699
First Posted: July 25, 2011
Last Update Posted: April 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Guillermo Tearney, Massachusetts General Hospital
  Purpose
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: Intervention Model: Single Group Assignment
Masking: None (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 Guillermo Tearney, 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 ]
    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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01401699


Locations
United States, Massachusetts
Massachussetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
Investigators
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
ClinicalTrials.gov Identifier: NCT01401699     History of Changes
Other Study ID Numbers: 2006-P-000203
5R21CA141884 ( U.S. NIH Grant/Contract )
First Submitted: July 20, 2011
First Posted: July 25, 2011
Last Update Posted: April 18, 2016
Last Verified: April 2016

Keywords provided by Guillermo Tearney, Massachusetts General Hospital:
Barrett's
esophagus
OCT
imaging

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases