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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01401699
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 109
• Location: 1
• Arm: 1
• Duration (Months): 62.5
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Barrett's Esophagus	Device: Optical Frequency Domain Imaging (OFDI)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 109 participants
• Allocation: N/A
• 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
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Nov 16, 2011
• Actual Study Completion Date: Nov 16, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Optical Frequency Domain imaging System Optical Frequency Domain Imaging (OFDI) balloon based imaging	Device: Optical Frequency Domain Imaging (OFDI); Optical Frequency Domain (OFDI) imaging of esophagus

Outcome Measures

Primary Outcome Measures

1. Number of Subjects in Which the Entire Distal Esophagus Can be Visualized Using the Balloon Based Optical Coherence Tomography Screening [Images will be acquired during the OFDI imaging session which should take an average of 5 minutes]

   Collected entire distal esophagus OFDI Images analyzed and compared to the images obtained during standard of care surveillance endoscopy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Guillermo Tearney, Professor of Pathology, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01401699
• Other Study ID Numbers: 2006-P-000203; 5R21CA141884
• First Posted: Jul 25, 2011
• Last Update Posted: Apr 12, 2019
• Last Verified: Apr 1, 2019

• Keywords provided by Guillermo Tearney, Professor of Pathology, Massachusetts General Hospital: Barrett's; esophagus; OCT; imaging
• Additional relevant MeSH terms: Barrett Esophagus

Study Results

Participant Flow

Arm/Group Title	Optical Frequency Domain Imaging System
Arm/Group Description	OFDI imaging Optical Frequency Domain Imaging (OFDI) System: OFDI Imaging of esophagus
Period Title: Overall Study
STARTED	109
COMPLETED	109
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Optical Frequency Domain Imaging System
Arm/Group Description	OFDI imaging Optical Frequency Domain Imaging (OFDI) System: OFDI Imaging of esophagus
Overall Participants	109
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	71 65.1%
>=65 years	38 34.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63 (11)
Sex: Female, Male (Count of Participants)
Female	33 30.3%
Male	76 69.7%
Region of Enrollment (Count of Participants)
United States	109 100%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects in Which the Entire Distal Esophagus Can be Visualized Using the Balloon Based Optical Coherence Tomography Screening
Description	Collected entire distal esophagus OFDI Images analyzed and compared to the images obtained during standard of care surveillance endoscopy.
Time Frame	Images will be acquired during the OFDI imaging session which should take an average of 5 minutes

Outcome Measure Data

Analysis Population Description

All subjects completed the study with no adverse events.

Arm/Group Title	Optical Frequency Domain Imaging
Arm/Group Description	Optical Frequency Domain imaging data
Measure Participants	109
Count of Participants [Participants]	109 100%

Adverse Events

Time Frame	During the imaging session
Arm/Group Title	Optical Frequency Domain Imaging System
Arm/Group Description	OFDI imaging Optical Frequency Domain Imaging (OFDI) System: OFDI Imaging of esophagus
All Cause Mortality
	Optical Frequency Domain Imaging System
	Affected / at Risk (%)	# Events
Total	0/109 (0%)
Serious Adverse Events
	Optical Frequency Domain Imaging System
	Affected / at Risk (%)	# Events
Total	0/109 (0%)
Other (Not Including Serious) Adverse Events
	Optical Frequency Domain Imaging System
	Affected / at Risk (%)	# Events
Total	0/109 (0%)
Investigations
aspiration	0/109 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.