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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

NCT ID: NCT04054154

Last Updated: 2025-11-10

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-29

Study Completion Date

2026-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Solid Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Shear Wave Elastography

Intervention Type DEVICE

Undergo shear wave elastography

Tumor Interstitial Fluid Pressure Measurement

Intervention Type PROCEDURE

Undergo tumor pressure measurement

Interventions

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Shear Wave Elastography

Undergo shear wave elastography

Intervention Type DEVICE

Tumor Interstitial Fluid Pressure Measurement

Undergo tumor pressure measurement

Intervention Type PROCEDURE

Other Intervention Names

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Transient Elastography

Eligibility Criteria

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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.

* Tumors involving bone.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Y Huang

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

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NCI-2019-02647

Identifier Type: REGISTRY

Identifier Source: secondary_id

2014-0038

Identifier Type: OTHER

Identifier Source: secondary_id

2014-0038

Identifier Type: -

Identifier Source: org_study_id