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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Neoplasm

Interventions

Type	Name	Description
DEVICE	Shear Wave Elastography	Undergo shear wave elastography
PROCEDURE	Tumor Interstitial Fluid Pressure Measurement	Undergo tumor pressure measurement

Timeline

• Start date: 2015-12-29
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2019-08-13
• Last updated: 2026-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study