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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03211780
• Other study ID #: 17-002253
• Status: Terminated
• Phase: N/A
• Start date: September 20, 2017
• Est. completion date: April 24, 2019

Study information

• Verified date: October 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: April 24, 2019
• Est. primary completion date: April 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determining malignant esophageal tissue from normal tissue	Determining malignant esophageal tissue from normal tissue by measurements using the General Electric LOGIQ E9 ultrasound system.	1 week

External Links

•   Mayo Clinic Clinical Trials