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
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Solid Neoplasm
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Device Feasibility
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04054154
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Steven Y Huang M.D. Anderson Cancer Center
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