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Device

Tumor Pressure and Stiffness Measurement for Cancer

N/A

Waitlist Available

Led By Steven Y Huang

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 days

Awards & highlights

Study Summary

This trial is studying how well two methods measure the pressure and stiffness inside tumors of patients with solid tumors.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include discomfort from the catheter insertion into the tumor during measurement, as well as risks typically associated with ultrasounds such as minor pain or bruising.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The change in Tumor pressure

The change in Tumor stiffness

Secondary outcome measures

Tumor pressure

Trial Design

1Treatment groups

Experimental Treatment

Group I: Device Feasibility (Millar Mikro-tip catheter, elastography)Experimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Shear Wave Elastography

2020

Completed Phase 2

~560

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,126 Total Patients Enrolled

3 Trials studying Tumors

1,244 Patients Enrolled for Tumors

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,775 Total Patients Enrolled

10 Trials studying Tumors

8,562 Patients Enrolled for Tumors

Steven Y HuangPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Tumor Interstitial Fluid Pressure Measurement (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04054154 — N/A

Tumors Research Study Groups: Device Feasibility (Millar Mikro-tip catheter, elastography)

Tumors Clinical Trial 2023: Tumor Interstitial Fluid Pressure Measurement Highlights & Side Effects. Trial Name: NCT04054154 — N/A

Tumor Interstitial Fluid Pressure Measurement (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04054154 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum patient enrollment for this clinical trial?

"Yes, the information featured on clinicaltrials.gov attests that this trial is actively recruiting participants. Originally posted on December 29th 2015 and most recently edited on August 1st 2022, the study has opened 25 spots at one specific site."

Answered by AI

Does this research endeavor have the capacity to accept new participants?

"This clinical trial is actively seeking participants, as indicated by the information posted on clinicaltrials.gov. It was initially made available on December 29th 2015 and has since been modified most recently on August 1st 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2015. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04054154.