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Completed

NCT Number: NCT04054154

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

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).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shear Wave Elastography

Device

Undergo shear wave elastography

Other names: Transient Elastography

Tumor Interstitial Fluid Pressure Measurement

Procedure

Undergo tumor pressure measurement

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2019
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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