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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 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

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,287 Total Patients Enrolled
3 Trials studying Tumors
1,234 Patients Enrolled for Tumors
M.D. Anderson Cancer CenterLead Sponsor
2,987 Previous Clinical Trials
1,798,208 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
~1 spots leftby Dec 2024
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