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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-20

Study Completion Date

2019-04-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Ultrasound

Group Type EXPERIMENTAL

General Electric LOGIQ E9 ultrasound system

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.