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

Not Applicable

Active, not recruiting

• Conditions: Solid Neoplasm
• Interventions: Device: Shear Wave Elastography; Procedure: Tumor Interstitial Fluid Pressure Measurement

• Registration Number: NCT04054154
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2015-12-29
• Study First Submitted: 2019-05-28
• Study First Submitted QC: 2019-08-09
• Study First Posted: 2019-08-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-08
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device Feasibility (Millar Mikro-tip catheter, elastography)	Shear Wave 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 Feasibility (Millar Mikro-tip catheter, elastography)	Tumor Interstitial Fluid Pressure Measurement	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States