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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03211780
Recruitment Status : Terminated (Terminated due to the inability to enroll and carry out study intervention.)
First Posted : July 7, 2017
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Dennis Wigle, Mayo Clinic

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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.
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 : September 20, 2017
Actual Primary Completion Date : April 24, 2019
Actual Study Completion Date : April 24, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03211780


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Dennis Wigle, MD, PhD Mayo Clinic
Principal Investigator: Matthew Urban, PhD Mayo Clinic
Additional Information:
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Responsible Party: Dennis Wigle, MD, PhD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03211780    
Other Study ID Numbers: 17-002253
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neoplasms