Trial Outcomes & Findings for a/LCI-OCT Pilot in Esophagus (NCT NCT04392167)

Last Updated: 2023-11-28

Results Overview

Sensitivity of the a/LCI-OCT probe to detect dysplasia as measured by percentage of correctly identified positive biopsies. The a/LCI-OCT measurement of mean nuclear size was compared with a pre-determined threshold of mean nuclear size (11.84 microns from Terry et al study) to categorize biopsy samples as dysplastic or non-dysplastic.

Recruitment status

COMPLETED

Study phase

Target enrollment

37 participants

Primary outcome timeframe

day 1

Results posted on

2023-11-28

Participant Flow

Participant milestones

Participant milestones
Measure	a/LCI-OCT Imaging of the Esophagus All participants who were able to swallow the a/LCI-OCT probe had a/LCI-OCT imaging of the esophagus. These participants then also had biopsies of the esophageal tissue that was imaged by the a/LCI-OCT probe.
Overall Study STARTED	37
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	a/LCI-OCT Imaging of the Esophagus All participants who were able to swallow the a/LCI-OCT probe had a/LCI-OCT imaging of the esophagus. These participants then also had biopsies of the esophageal tissue that was imaged by the a/LCI-OCT probe.
Overall Study unable to swallow a/LCI-OCT probe	6

Baseline Characteristics

One participant did not report age.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	a/LCI-OCT Imaging of the Esophagus n=37 Participants All participants who were able to swallow the a/LCI-OCT probe had a/LCI-OCT imaging of the esophagus. These participants then also had biopsies of the esophageal tissue that was imaged by the a/LCI-OCT probe.
Age, Continuous	65.4 years STANDARD_DEVIATION 7.8 • n=36 Participants • One participant did not report age.
Sex: Female, Male Female	8 Participants n=36 Participants • One participant did not report sex.
Sex: Female, Male Male	28 Participants n=36 Participants • One participant did not report sex.
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=37 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=37 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=37 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants
Race (NIH/OMB) Asian	0 Participants n=37 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants
Race (NIH/OMB) Black or African American	1 Participants n=37 Participants
Race (NIH/OMB) White	33 Participants n=37 Participants
Race (NIH/OMB) More than one race	0 Participants n=37 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=37 Participants
Region of Enrollment United States	37 Participants n=37 Participants
Stage of Barrett's Esophagus non-dysplastic Barrett's Esophagus	12 Participants n=37 Participants
Stage of Barrett's Esophagus Barrett's Esophagus with low grade dysplasia	7 Participants n=37 Participants
Stage of Barrett's Esophagus Barrett's Esophagus with high grade dysplasia	16 Participants n=37 Participants
Stage of Barrett's Esophagus history of Barrett's Esophagus with CEIM (complete eradication of intestinal metaplasia)	1 Participants n=37 Participants
Stage of Barrett's Esophagus normal asymptomatic control without history of Barrett's Esophagus	1 Participants n=37 Participants

PRIMARY outcome

Timeframe: day 1

Outcome measures

Outcome measures
Measure	a/LCI-OCT Imaging of the Esophagus n=7 positive biopsies a/LCI-OCT imaging probe: a/LCI and OCT imaging measurements of several locations in the esophagus esophageal biopsy: biopsies of esophageal tissue imaged by a/LCI-OCT probe
Percentage of Correctly Identified Positive (Dysplastic) Biopsies	100.0 percentage of correct identifications

PRIMARY outcome

Timeframe: day 1

Specificity of the a/LCI-OCT probe to detect absence of dysplasia as measured by percentage of correctly identified negative biopsies. The a/LCI-OCT measurement of mean nuclear size was compared with a pre-determined threshold of mean nuclear size (11.84 microns from Terry et al study) to categorize biopsy samples as dysplastic or non-dysplastic.

Outcome measures

Outcome measures
Measure	a/LCI-OCT Imaging of the Esophagus n=43 negative biopsies a/LCI-OCT imaging probe: a/LCI and OCT imaging measurements of several locations in the esophagus esophageal biopsy: biopsies of esophageal tissue imaged by a/LCI-OCT probe
Percentage of Correctly Identified Negative (Non-Dysplastic) Biopsies	93.0 percentage of correct identifications

SECONDARY outcome

Timeframe: day 1

percentage of participants that had adequate tissue contact to acquire high quality a/LCI-OCT images

Outcome measures

Outcome measures
Measure	a/LCI-OCT Imaging of the Esophagus n=37 Participants a/LCI-OCT imaging probe: a/LCI and OCT imaging measurements of several locations in the esophagus esophageal biopsy: biopsies of esophageal tissue imaged by a/LCI-OCT probe
Percentage of Participants With Adequate Tissue Contact to Acquire a High Quality Image	83.8 percentage of participants

Adverse Events

a/LCI-OCT Imaging of the Esophagus

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	a/LCI-OCT Imaging of the Esophagus n=37 participants at risk All participants who were able to swallow the a/LCI-OCT probe had a/LCI-OCT imaging of the esophagus. These participants then also had biopsies of the esophageal tissue that was imaged by the a/LCI-OCT probe.
Surgical and medical procedures sore throat	54.1% 20/37 • 1 week Participants were contacted 1 week after a/LCI-OCT imaging to assess any adverse events.
Surgical and medical procedures throat tightness / trouble swallowing	10.8% 4/37 • 1 week Participants were contacted 1 week after a/LCI-OCT imaging to assess any adverse events.

Additional Information

Dr. Adam Wax

Duke University

Phone: 919-660-5143

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place