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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04054154

Enrollment

Registered

2019-08-13

Start date

2015-12-29

Completion date

2026-01-01

Last updated

2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Neoplasm

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).

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.

Interventions

DEVICEShear Wave Elastography

Undergo shear wave elastography

PROCEDURETumor Interstitial Fluid Pressure Measurement

Undergo tumor pressure measurement

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
The change in Tumor pressure	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.
The change in Tumor stiffness	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

Measure	Time frame	Description
Tumor pressure	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026