DONTBIOPCE: Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy

• Sponsor: Mauna Kea Technologies (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00795184
• Collaborator: Cellvizio Inc. (Industry), Emissary International LLC (Industry)
• Enrollment: 122
• Locations: 5
• Arms: 2
• Duration (Months): 15
• Patients Per Site: 24.4
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

This study will collect data from patients routinely undergoing a endoscopic surveillance and Cellvizio endomicroscopy procedure due to confirmed Barrett's esophagus. The objective is to determine if endomicroscopy images collected using the marketed Cellvizio device may help endoscopists more accurately diagnose, in conjunction with traditional tissue sampling techniques, whether a suspected lesion is malignant or benign.

Condition or Disease	Intervention/Treatment	Phase
Barrett Syndrome; Barrett's Syndrome; Barrett's Esophagus; Barrett Esophagus; Adenocarcinoma	Device: Imaging procedures (NBI); Device: HDWLE; Device: pCLE	N/A

Detailed Description

This is a longitudinal observational study were imaging procedures are allocated in a random order to directly address the low sensitivity and specificity of enhanced macroscopic endoscopic imaging devices by determining whether probe-based Confocal Laser Endomicroscopy (pCLE), as a supplement to Narrow Band Imaging (NBI) can further improve sensitivity and specificity to a level that would be acceptable to avoid random biopsy, and better direct biopsy of suspicious areas. The study is also addressing pCLE as a supplement to standard white light endoscopy and random biopsy alone. In fact, the study is powered to evaluate per lesion sensitivity and specificity of confocal imaging as applied to lesions identified by white light endoscopy. Therefore, the study addresses the shortcomings of standard white light endoscopy (high number of random biopsies, less than ideal directed biopsy of suspicious areas) and the primary shortcomings of Narrow Band Imaging (NBI) (low specificity with resultant high false positives, again resulting in many unnecessary biopsies).

Study Design

• Study Type: Interventional
• Actual Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Detection Of Neoplastic Tissue in Barrett's Esophagus With In vivO Probe-based Confocal Endomicroscopy
• Study Start Date: Nov 1, 2008
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: Imaging Procedures HDWLE first NBI second and pCLE All patients undergo both endoscopic imaging procedures and then the endomicroscopy procedure; the endoscopic imaging procedures being performed back to back by two endoscopists, blinded to each other.	Device: Imaging procedures (NBI); Imaging procedures (pCLE) and (NBI) - All patients undergo both procedures back to back by two endoscopists, blinded to each other, in randomized order. Procedure 1: Standard endoscopic procedure The patient receives white light endoscopy (WLE) examination. All visible lesions are noted and photographed. No biopsy is taken until both procedures are complete. Procedure 2: NBI endoscopic procedure The patient receives a NBI endoscopy examination. All visible and NBI abnormal lesions are noted and photographed. After both procedures are complete and all sites are unblinded to both endoscopists. pCLE with Cellvizio and physical biopsies are performed at all sites plus 4 quadrant sites.; Device: HDWLE; Device: pCLE; Other Names: Cellvizio
Other: Imaging Procedures NBI first HDWLE second and pCLE All patients undergo both endoscopic imaging procedures and then the endomicroscopy procedure; the endoscopic imaging procedures being performed back to back by two endoscopists, blinded to each other.	Device: Imaging procedures (NBI); Imaging procedures (pCLE) and (NBI) - All patients undergo both procedures back to back by two endoscopists, blinded to each other, in randomized order. Procedure 1: Standard endoscopic procedure The patient receives white light endoscopy (WLE) examination. All visible lesions are noted and photographed. No biopsy is taken until both procedures are complete. Procedure 2: NBI endoscopic procedure The patient receives a NBI endoscopy examination. All visible and NBI abnormal lesions are noted and photographed. After both procedures are complete and all sites are unblinded to both endoscopists. pCLE with Cellvizio and physical biopsies are performed at all sites plus 4 quadrant sites.; Device: HDWLE; Device: pCLE; Other Names: Cellvizio

Outcome Measures

Primary Outcome Measures

1. Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus. [Centralized histopathology confirmation within 4-6 weeks]

   Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using Probe-based Confocal Laser Endomicroscopy (pCLE) Associated With White Light Endoscopy (WLE), or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients with documented or suspected Barrett's esophagus presenting for endoscopy

2. Age > 18 years

3. Ability to provide written, informed consent

Exclusion Criteria:

1. Presence of erosive esophagitis

2. Inability to obtain biopsies due to anticoagulation, varices, etc.

3. Allergy to fluorescein, pregnancy

4. Presence of an esophageal mass other than small 10mm or less nodules

5. Renal insufficiency

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Jacksonville	Florida	United States	32224
2	Veterans Affairs Hospital	Kansas City	Missouri	United States	64128
3	New York Presbyterian Hospital/Columbia University Medical Center	New York	New York	United States	10032
4	Centre Hospitalier Universitaire	Nantes		France	44093 Cedex 1
5	Klinikum rechts der Isar	Munich	Bayern	Germany

Sponsors and Collaborators

• Mauna Kea Technologies
• Cellvizio Inc.
• Emissary International LLC

Investigators

• Principal Investigator: Prateek Sharma, MD, Veterans Affairs Hospital, Kansas City

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mauna Kea Technologies
• ClinicalTrials.gov Identifier: NCT00795184
• Other Study ID Numbers: MKT-2008-BE-01
• First Posted: Nov 21, 2008
• Last Update Posted: May 3, 2016
• Last Verified: May 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Mauna Kea Technologies: Barrett's Esophagus; EsoGastroDuodenoscopy; Barrett's Carcinoma; adenocarcinoma; Cellvizio; endomicroscopy; random biopsy
• Additional relevant MeSH terms: Adenocarcinoma; Barrett Esophagus; Syndrome

Study Results

Participant Flow

Arm/Group Title	HDWLE First NBI Second and pCLE	NBI First HDWLE Second and pCLE
Arm/Group Description
Period Title: Overall Study
STARTED	65	57
COMPLETED	57	44
NOT COMPLETED	8	13

Baseline Characteristics

Arm/Group Title	Group 1
Arm/Group Description	NBI-pCLE
Overall Participants	101
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.1 (11.52)
Sex: Female, Male (Count of Participants)
Female	14 13.9%
Male	87 86.1%
Region of Enrollment (participants) [Number]
France	9 8.9%
United States	62 61.4%
Germany	30 29.7%

Outcome Measures

1. Primary Outcome

Title	Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using pCLE Associated With WLE, or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus.
Description	Comparative Histopathology-confirmed Measures of Per Lesion Sensitivity and Per Lesion Specificity, by Using Probe-based Confocal Laser Endomicroscopy (pCLE) Associated With White Light Endoscopy (WLE), or WLE Alone, for the Detection of High Grade Dysplasia and Early Carcinoma in Barrett's Esophagus.
Time Frame	Centralized histopathology confirmation within 4-6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	HDWLE	NBI (Narrow Band Imaging)	pCLE	HDWLE+NBI+pCLE	HDWLE+pCLE	HDWLE+NBI
Arm/Group Description
Measure Participants	101	101	101	101	101	101
Measure Biopsy sites	874	874	874	874	874	874
Sensitivity	34.2	41.7	62.5	75.8	68.3	45.0
Specificity	92.7	90.5	92.7	84.2	87.8	88.2

Adverse Events

Time Frame	Acutely during the procedure - within the day
Arm/Group Title	Group 1
Arm/Group Description	NBI-pCLE or pCLE-NBI
All Cause Mortality
	Group 1
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Group 1
	Affected / at Risk (%)	# Events
Total	0/122 (0%)
Other (Not Including Serious) Adverse Events
	Group 1
	Affected / at Risk (%)	# Events
Total	0/122 (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.