Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Neoplasm | Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Shear Wave Elastography | Device | — | UNRESOLVED |
| Tumor Interstitial Fluid Pressure Measurement | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Device Feasibility (Millar Mikro-tip catheter, elastography)
- description
- 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.
- interventionNames
- Device: Shear Wave Elastography
- Procedure: Tumor Interstitial Fluid Pressure Measurement
Primary outcomes (2)
- measure
- The change in Tumor pressure
- timeFrame
- Up to 30 days
- description
- 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.
- measure
- The change in Tumor stiffness
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available