Use of Intra-Operative Shear Wave Ultrasound Vibrometry for Characterization of Esophageal Malignant Tumors

Sponsor

Mayo Clinic (Other)

Overall Status

Terminated

CT.gov ID

NCT03211780

Collaborator

(none)

Enrollment

Location

Arm

19.1

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Using the analysis of group velocity for a screening application and then higher order analysis based on the elastic and viscious components of the shear modulus may allow discrimination between extent of tumor invasion through the esophageal wall if appropriately correlated with pathological findings.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Device: General Electric LOGIQ E9 ultrasound system	N/A

Detailed Description

Use of ultrasound-based vibrometry in this setting would allow for a relatively simple study and translation of clinical practice, as the same devices are already used in this setting, and operators have familiarity with the equipment. Incorporating another additional method to generate contrast for determining malignant tissue from normal based on biomechanical properties with the same probe would have benefit as an additional diagnostic modality.

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Shear wave vibrometry and B-mode imaging will be performed after esophageal distension with a fluid filled balloon intra-operatively.Shear wave vibrometry and B-mode imaging will be performed after esophageal distension with a fluid filled balloon intra-operatively.

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

Use of Intra-Operative Shear Wave Ultrasound Vibrometry for Characterization of Esophageal Malignant Tumors

Actual Study Start Date :

Sep 20, 2017

Actual Primary Completion Date :

Apr 24, 2019

Actual Study Completion Date :

Apr 24, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ultrasound	Device: General Electric LOGIQ E9 ultrasound system Patients will be brought to the operating room in line with standard clinical practice and after esophageal exposure, but before surgical mobilization of the esophagus, shear wave vibrometry and B-mode imaging will be performed after esophageal distension with a fluid filled balloon intra-operatively.

Arm

Intervention/Treatment

Experimental: Ultrasound

Device: General Electric LOGIQ E9 ultrasound system

Patients will be brought to the operating room in line with standard clinical practice and after esophageal exposure, but before surgical mobilization of the esophagus, shear wave vibrometry and B-mode imaging will be performed after esophageal distension with a fluid filled balloon intra-operatively.

Outcome Measures

Primary Outcome Measures

Determining malignant esophageal tissue from normal tissue [1 week]
Determining malignant esophageal tissue from normal tissue by measurements using the General Electric LOGIQ E9 ultrasound system.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

≥ 18 years old
Scheduled to undergo esophageal reconstruction for presumed or known esophageal cancer
Subject is able to understand the study procedures and provide informed consent.

Exclusion Criteria:

Subject is pregnant or breast feeding.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Dennis Wigle, MD, PhD, Mayo Clinic
Principal Investigator: Matthew Urban, PhD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Dennis Wigle, MD, PhD, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT03211780

Other Study ID Numbers:

17-002253

First Posted:

Jul 7, 2017

Last Update Posted:

Oct 4, 2019

Last Verified:

Oct 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Oct 4, 2019