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Ultrasound & Elastography for Soft Tissue Sarcoma
Phase < 1
Waitlist Available
Led By Mittul Gulati
Research Sponsored by University of Southern California
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 9 weeks
Awards & highlights
Study Summary
This trial uses ultrasound & elastography to predict how patients with soft tissue sarcomas will respond to treatment, without using radiation.
Who is the study for?
This trial is for patients with soft tissue or bone sarcomas that can be measured on scans. It's open to those who can consent and follow the study rules, are candidates for pre-surgery treatment like chemo, radiation, or immunotherapy, and not currently pregnant or allergic to perflutren.Check my eligibility
What is being tested?
The trial tests real-time contrast-enhanced ultrasonography (CEUS) and shear wave elastography (SWE), both imaging techniques using sound waves instead of x-rays. They're being studied to see if they can predict how well a patient responds to treatment before surgery.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the Definity injection used in CEUS. Since SWE is a non-invasive imaging technique similar to an ultrasound, it carries minimal risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 9 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 9 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Inter-reader agreement for sequential contrast-enhanced ultra sound for evaluating treatment response as determined by kappa coefficient
Trial Design
1Treatment groups
Experimental Treatment
Group I: Real-time CEUS and SWEExperimental Treatment4 Interventions
Patients undergo real-time CEUS and SWE at baseline, 6 weeks after initiation of neoadjuvant therapy, and 9 weeks after initiation of neoadjuvant therapy (prior to surgery).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SWE
2014
Completed Early Phase 1
~30
Real-Time CEUS
2014
Completed Early Phase 1
~30
Perflutren
FDA approved
Philips Shear Wave Elastography
2014
Completed Early Phase 1
~30
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
905 Previous Clinical Trials
1,596,253 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,464 Total Patients Enrolled
Mittul GulatiPrincipal InvestigatorUniversity of Southern California
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently receiving or being considered for neoadjuvant therapy, which includes treatments like chemotherapy, radiation, or immunotherapy.You are allergic to the perflutren agent used in the study.You have a heart condition called cardiac shunt or a lung condition called pulmonary hypertension.
Research Study Groups:
This trial has the following groups:- Group 1: Real-time CEUS and SWE
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are included in this research project?
"This investigation is no longer actively seeking participants. Initially posted on December 24th 2014, the study was last updated August 19th 2022. Patients with soft tissue sarcoma can find 446 other studies that are open for enrollment and there are currently 19 trials recruiting those with specialized needs related to SWE."
Answered by AI
Are there any other experiments involving SWE that have already been conducted?
"At present, there are 19 SWE studies taking place. One of those trials is in its third and final phase. Although the majority of these research projects center around Philadelphia, Pennsylvania, clinical locations span 26 cities across America."
Answered by AI
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