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

This study is currently recruiting participants.

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Contacts and Locations

Verified July 2017 by Dennis Wigle, Mayo Clinic

Sponsor:

Information provided by (Responsible Party):

Dennis Wigle, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT03211780

First received: July 3, 2017

Last updated: July 6, 2017

Last verified: July 2017

History of Changes

Purpose

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	Intervention
Esophageal Cancer	Device: General Electric LOGIQ E9 ultrasound system


Study Type:	Interventional
Study Design:	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. Masking: No masking Primary Purpose: Device Feasibility
Official Title:	Use of Intra-Operative Shear Wave Ultrasound Vibrometry for Characterization of Esophageal Malignant Tumors

Resource links provided by NLM:

MedlinePlus related topics: Ultrasound

Genetic and Rare Diseases Information Center resources: Esophageal Cancer

U.S. FDA Resources

Further study details as provided by Dennis Wigle, Mayo Clinic:

Primary Outcome Measures:

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


Estimated Enrollment:	20
Anticipated Study Start Date:	July 2017
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	December 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03211780

Contacts


Contact: Karlyn Pierson, RN	507-538-1960	pierson.karlyn@mayo.edu
Contact: Bettie Lechtenberg	507-266-4819	lechtenberg.bettie@mayo.edu

Locations


United States, Minnesota
Mayo Clinic in Rochester	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Karlyn E Pierson, RN 507-538-1960 pierson.karlyn@mayo.edu
Principal Investigator: Dennis A Wigle, MD, PhD

Sponsors and Collaborators

Mayo Clinic

Investigators


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

More Information


Responsible Party:	Dennis Wigle, MD, PhD, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT03211780 History of Changes
Other Study ID Numbers:	17-002253
Study First Received:	July 3, 2017
Last Updated:	July 6, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		Yes
Device Product Not Approved or Cleared by U.S. FDA:		No
Pediatric Postmarket Surveillance of a Device Product:		No
Product Manufactured in and Exported from the U.S.:		No

Additional relevant MeSH terms:


Esophageal Neoplasms Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site	Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases

ClinicalTrials.gov processed this record on July 11, 2017

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