Tumor Pressure and Stiffness Measurement for Cancer

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well two tools measure pressure and stiffness inside tumors for patients with solid tumors undergoing a biopsy. The Millar Mikro-tip catheter measures pressure, while shear wave elastography (similar to an ultrasound) assesses stiffness. The goal is to determine if pressure and stiffness correlate with fibrosis, which involves the thickening and scarring of tissue. Patients may qualify if they have a solid tumor, require a biopsy, and can provide consent. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could enhance future diagnostic techniques.

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 prior data suggests that these measurement techniques are safe for assessing tumor pressure and stiffness?

Research has shown that shear wave elastography and measuring tumor interstitial fluid pressure are generally safe techniques. Studies have found that shear wave elastography, which uses sound waves to assess tissue stiffness, is well-tolerated. It helps doctors distinguish between non-cancerous and cancerous breast lumps without causing harm.

Measuring tumor interstitial fluid pressure primarily monitors tumor conditions and does not involve treatment. This method measures the pressure inside a tumor, which is typically higher than in normal tissues. Current research focuses on the effectiveness of these measurements rather than any harmful side effects.

Overall, both methods are non-invasive and designed to safely gather information about tumors.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it offers a new way to assess tumors by directly measuring tumor stiffness and pressure. Unlike traditional imaging methods, this approach uses a Millar Mikro-tip catheter and shear wave elastography to provide real-time data on tumor characteristics. This could lead to more precise and personalized treatment plans by better understanding the tumor's physical properties, potentially improving patient outcomes.

What evidence suggests that these measurement techniques are effective for assessing tumor pressure and stiffness?

Research has shown that shear wave elastography, which participants in this trial will undergo, effectively measures tumor stiffness. Studies have found that this stiffness relates to low oxygen levels in the tumor and other important cancer indicators, making it a useful tool for better understanding tumors.

Similarly, participants in this trial will have their tumor interstitial fluid pressure measured. This measurement is important for predicting cancer progression and treatment response. High pressure inside a tumor often links to worse outcomes and lower survival rates. This measurement can help doctors make better treatment decisions and understand tumor behavior more accurately.46789

Who Is on the Research Team?

SY

Steven Y Huang

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Device Feasibility (Millar Mikro-tip catheter, elastography)Experimental Treatment2 Interventions

Find a Clinic Near You

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+

Citations

Combined use of super-resolution ultrasound imaging and ...Shear-wave elastography (SWE) provides valuable stiffness within breast masses, making it a useful supplement to conventional ultrasound ...
Supersonic shear waves quantitative elastography and ...The sensitivity of MR imaging for detection of breast cancer is very high and approaches 100% for invasive carcinoma. However, the specificity is low and varies ...
Shear Wave Elasticity Measurements of Three ...Ultrasound shear wave elastography has recently demonstrated that both the mean and the spatial variation of the elasticity of a tumor aid tumor ...
Early Tumor Assessment with Ultrasound & ElastographyShear wave elastography is a functional imaging technique that measures the stiffness or elasticity of tissues. It works by generating mechanical shear waves ...
Tumor stiffness measured by shear wave elastography ...Tumor stiffness measured by shear wave elastography correlates with tumor hypoxia as well as histologic biomarkers in breast cancer | Cancer ...
Quantitative shear wave ultrasound elastographyWe have shown that several shear wave elastography parameters are useful in aiding benign/malignant differentiation of solid breast masses. Shear wave ...
The diagnostic performance of shear wave speed (SWS ...With cut-off SWS value of 3.52 m/s in E-max, sensitivity of 69.8%, specificity of 81.5%, and accuracy of 77.6% were achieved. SWS imaging is a valuable tool in ...
Combined use of super-resolution ultrasound imaging and ...Shear-wave elastography (SWE) is a technique that quantitatively measures tissue elastic modulus value and provides a potentially valuable tool ...
Qualitative and quantitative analysis with a novel shear ...To evaluate the diagnostic performance of a new two-dimensional shear wave speed (SWS) imaging (ie Toshiba shear wave elastography, T-SWE) in differential ...
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