Tumor Pressure and Stiffness Measurement for Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

27 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Shear Wave Elastography (SWE) for measuring tumor pressure and stiffness in cancer?

Research shows that high interstitial fluid pressure (IFP) in tumors is linked to poor outcomes and affects how well treatments work. Non-invasive imaging methods like elastography can help measure IFP, which may improve understanding of the tumor environment and aid in developing better treatment strategies. ^{1 2 3 4 5}

Is measuring tumor pressure and stiffness safe for humans?

The research does not provide specific safety data for humans, but it discusses non-invasive methods like imaging to measure tumor pressure, which are generally considered safe. ^{1 2 4 5 6}

How is the Tumor Interstitial Fluid Pressure Measurement treatment different from other cancer treatments?

This treatment is unique because it focuses on measuring the pressure inside a tumor noninvasively, using advanced imaging techniques like MRI, to better understand the tumor's environment and improve treatment strategies. Unlike traditional methods that require invasive procedures, this approach aims to provide valuable information about the tumor's behavior and response to therapies without the need for surgery. ^{1 7 8 9 10}

Research Team

Steven Y Huang

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for patients with solid organ tumors (not including bone) who are scheduled for a biopsy at MD Anderson and can give informed consent. It's not open to pregnant women or those with tumors smaller than 1.5 cm or larger than 5 cm for the first assessment, and less than 1 cm for the second.

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

Your tumors have spread to your bones.

Pregnant women (these patients will be tested for pregnancy before they are scheduled for a diagnostic or research biopsy per inclusion criteria #1).

Tumor size < 1.5 cm or > 5 cm in size on pre-procedural imaging for 1st assessment and < 1 cm for 2nd assessment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Biopsy and Measurement

Patients undergo stiffness assessment of the tumor with shear wave elastography and pressure measurements using a Millar Mikro-tip catheter before and after the biopsy is collected

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

30 days

2 visits (in-person)

Treatment Details

Interventions

• Shear Wave Elastography
• Tumor Interstitial Fluid Pressure Measurement

Trial Overview The study tests how well a Millar Mikro-tip catheter can measure tumor pressure and shear wave elastography can measure tumor stiffness in patients undergoing ultrasound-guided biopsies of solid tumors.

Participant Groups

Group I: Device Feasibility (Millar Mikro-tip catheter, elastography) Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Interstitial fluid pressure as an emerging biomarker in solid tumors. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Interstitial fluid pressure in breast cancer, benign breast conditions, and breast parenchyma. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Interstitial fluid pressure and vascularity of intradermal and intramuscular human tumor xenografts. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Interstitial pressure gradients in tissue-isolated and subcutaneous tumors: implications for therapy. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Subharmonic-Aided Pressure Estimation for Monitoring Interstitial Fluid Pressure in Tumors: Calibration and Treatment with Paclitaxel in Breast Cancer Xenografts. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Interstitial fluid pressure in cervical carcinoma: within tumor heterogeneity, and relation to oxygen tension. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Towards noninvasive estimation of tumour pressure by utilising MR elastography and nonlinear biomechanical models: a simulation and phantom study. [2021]

8. England pubmed.ncbi.nlm.nih.gov

A model-based approach to investigate the effect of elevated interstitial fluid pressure on strain elastography. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Estimation of Tumor Interstitial Fluid Pressure (TIFP) Noninvasively. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Dynamic schema for near infrared detection of pressure-induced changes in solid tumors. [2019]