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

NCT04054154 | Completed FDA Device

• 2 other identifiers: 2014-0038NCI-2019-02647
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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).

Conditions

Solid Neoplasm

Outcome Measures

Primary Outcomes (2)

• The change in Tumor pressure

  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.

  Up to 30 days

• The change in Tumor stiffness

  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.

  Up to 30 days

Secondary Outcomes (1)

• Tumor pressure

  Up to 30 days

Study Arms (1)

Device Feasibility (Millar Mikro-tip catheter, elastography)

EXPERIMENTAL

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: Shear Wave Elastography; Procedure: Tumor Interstitial Fluid Pressure Measurement

Interventions

Tumor Interstitial Fluid Pressure Measurement PROCEDURE

Undergo tumor pressure measurement

Device Feasibility (Millar Mikro-tip catheter, elastography)

Shear Wave Elastography DEVICE

Undergo shear wave elastography

Also known as: Transient Elastography

Device Feasibility (Millar Mikro-tip catheter, elastography)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Tumor size \< 1.5 cm or \> 5 cm in size on pre-procedural imaging for 1st assessment and \< 1 cm for 2nd assessment
• Tumors involving bone.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

Study Officials

• Steven Y Huang

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: August 13, 2019
• Study Start: December 29, 2015
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2025-01

Locations

US (1)