Clinical trial NCT01401699: Optical Coherence Tomography (OCT) Based Screening of Esophagus and Gastroesophageal Junction
Official title: Optical Coherence Tomography Based Screening and Surveillance of Esophagus and Gastroesophageal Junction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett's Esophagus
Keywords: Barrett's
esophagus
OCT
imaging
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-07-25
Enrollment: 109
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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 .

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 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

Primary outcomes:
measure: Number of Subjects in Which the Entire Distal Esophagus Can be Visualized Using the Balloon Based Optical Coherence Tomography Screening
timeFrame: Images will be acquired during the OFDI imaging session which should take an average of 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachussetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachussetts General Hospital
name: Guillermo Tearney, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachussetts General Hospital
name: Norman Nishioka, MD
role: PRINCIPAL_INVESTIGATOR
References: