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An Investigational Device (Millar Mikro-Tip Catheter) and Imaging Scan (Shear Wave Elastography) in Measuring Tumor Pressure and Stiffness in Patients With Solid Tumors Undergoing Ultrasound-Guided Biopsy

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ClinicalTrials.gov Identifier: NCT04054154
Recruitment Status : Recruiting
First Posted : August 13, 2019
Last Update Posted : August 3, 2022
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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Brief Summary:
This trial studies how well a Millar Mikro-tip catheter and shear wave elastography measure pressure and stiffness inside tumors among patients with solid tumors undergoing an ultrasound-guided biopsy. A Millar Mikro-tip catheter measures the pressure inside the tumor. Shear wave elastography is similar to an ultrasound and uses sound waves to vibrate the tissue in order to study tissue stiffness. These measurements may help doctors learn if pressure and stiffness are related to intratumoral fibrosis (the thickening and scarring of connective tissue).

Condition or disease Intervention/treatment Phase
Solid Neoplasm Device: Shear Wave Elastography Procedure: Tumor Interstitial Fluid Pressure Measurement Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the feasibility of measuring tumor intratumoral pressures in vivo using a commercially available, sterile, single use, cardiovascular catheter device.

II. To determine the feasibility of measuring tumor intratumoral stiffness in vivo using a commercially available shear wave elastography with ultrasound.

SECONDARY OBJECTIVES:

I. To assess the relationship of tumor pressure, stiffness, and fibrosis.

OUTLINE:

Patients scheduled for an ultrasound-guided tumor biopsy undergo stiffness assessment of the tumor with shear wave elastography over 2 minutes and pressure measurements of the tumor using a Millar Mikro-tip catheter before and after the biopsy is collected.

After completion of the study, patients are followed up at 24-48 hours and at 30 days.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Pilot Study to Evaluate the Feasibility of Measuring (a) Intratumoral Pressures Using a Novel Piezo- Resistive Semiconductor Catheter and (b) Intratumoral Stiffness Using Shear Wave Elastography With Ultrasound
Actual Study Start Date : December 29, 2015
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Device Feasibility (Millar Mikro-tip catheter, elastography)
Patients scheduled for an ultrasound-guided tumor biopsy undergo stiffness assessment of the tumor with shear wave elastography over 2 minutes and pressure measurements of the tumor using a Millar Mikro-tip catheter before and after the biopsy is collected.
 Device: Shear Wave Elastography
Undergo shear wave elastography
Other Name: Transient Elastography

Procedure: Tumor Interstitial Fluid Pressure Measurement
Undergo tumor pressure measurement


Outcome Measures
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Primary Outcome Measures :
  1. The change in Tumor pressure [ Time Frame: Up to 30 days ]
    Measured by Millar Microcath (Millar Mikro-Tip Pressure Catheter). Tumor pressure and its change will be summarized using mean, standard deviation, and range by time point.

  2. The change in Tumor stiffness [ Time Frame: Up to 30 days ]
    Measured by General Electric LOGIQ Shear Wave Elastography. Tumor stiffness and its change will be summarized using mean, standard deviation, and range by time point.


Secondary Outcome Measures :
  1. Tumor pressure [ Time Frame: Up to 30 days ]
    As a secondary endpoint, the relationship of tumor pressure with tumor fibrosis will be assessed for each patient. An ordinary least squares regression will be fit to the data to investigate the potential relationship between tumor stiffness, pressure, and fibrosis.


Eligibility Criteria
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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:

  • Patients who are scheduled for at least one biopsy (diagnostic or research) for solid organ tumors (excluding bone) at MD Anderson.
  • Patients who are able to understand and give consent to participation in the study.

Exclusion Criteria:

  • Tumor size < 1.5 cm or > 5 cm in size on pre-procedural imaging for 1st assessment and < 1 cm for 2nd assessment
  • Pregnant women (these patients will be tested for pregnancy before they are scheduled for a diagnostic or research biopsy per inclusion criteria #1).
  • Tumors involving bone.
Contacts and Locations
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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): NCT04054154


Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Steven Y. Huang    713-794-1152      
Principal Investigator: Steven Y. Huang         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Steven Y Huang M.D. Anderson Cancer Center
More Information
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Additional Information:

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04054154    
Other Study ID Numbers: 2014-0038
NCI-2019-02647 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2014-0038 ( Other Identifier: M D Anderson Cancer Center )
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes