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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Massachusetts General Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Guillermo Tearney, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01401699
First received: July 20, 2011
Last updated: February 26, 2012
Last verified: February 2012
  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: 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

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


Estimated Enrollment: 300
Study Start Date: September 2006
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OFDI imaging
OFDI imaging
Device: optical frequency domain imaging (OFDI) system
Imaging of esophagus with OFDI system

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401699

Contacts
Contact: Guillermo Tearney, MD PhD 617-724-2979 gtearney@partners.org
Contact: Mireille Rosenberg, PhD 617-726-9145 mrosenberg@partners.org

Locations
United States, Massachusetts
Massachussetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Norman Nishioka, MD    617-726-4422    nnishioka@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Guillermo Tearney, MD PhD Massachussetts General Hospital
Principal Investigator: Norman Nishioka, MD Massachussetts General Hospital
  More Information

No publications provided

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
Study First Received: July 20, 2011
Last Updated: February 26, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 29, 2014