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
概览
- 阶段
- 不适用
- 干预措施
- Shear Wave Elastography
- 疾病 / 适应症
- Solid Neoplasm
- 发起方
- M.D. Anderson Cancer Center
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- The change in Tumor stiffness
- 状态
- 已完成
- 最后更新
- 3个月前
概览
简要总结
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).
详细描述
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.
研究者
入排标准
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Device Feasibility (Millar Mikro-tip catheter, 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.
干预措施: Shear Wave Elastography
Device Feasibility (Millar Mikro-tip catheter, 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.
干预措施: Tumor Interstitial Fluid Pressure Measurement
结局指标
主要结局
The change in Tumor stiffness
时间窗: 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
时间窗: 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.
次要结局
- Tumor pressure(Up to 30 days)