10 Participants NeededMy employer runs this trial

Contrast-Enhanced Ultrasound for Soft Tissue Sarcoma

KN
Overseen ByKibo Nam, PhD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: Thomas Jefferson University
Stay on Your Current MedsYou can continue your current medications while participating
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 explores a new method of using ultrasound imaging to plan and predict responses to radiation therapy (RT) for soft tissue sarcoma, a cancer that begins in tissues like muscle or fat. The researchers will employ a special ultrasound technique called contrast-enhanced ultrasound (CEUS) with Definity, a contrast agent, to determine if it provides better images of the tumor's blood flow and pressure. This could help doctors assess how well the tumor responds to treatment. Individuals with confirmed soft tissue sarcoma in the trunk or limbs, scheduled to receive RT before surgery, might be suitable for this study. As an Early Phase 1 trial, this research aims to understand how the ultrasound technique functions in people, offering participants a chance to contribute to groundbreaking advancements in cancer treatment.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that contrast-enhanced ultrasound is safe for imaging guidance in soft tissue sarcoma?

Research has shown that Definity, the ultrasound contrast agent used in this study, is generally safe for many people. Patients with heart and lung conditions have used it without major problems. However, reports of serious heart and lung reactions exist, so awareness of these risks is important. Those allergic to any ingredients in Definity should not use it. Discuss all health conditions with a doctor before joining any trial.12345

Why are researchers excited about this trial?

Researchers are excited about the use of Contrast-Enhanced Ultrasound (CEUS) with Definity for soft tissue sarcoma because it offers a non-invasive way to visualize tumors more clearly than traditional imaging methods. Unlike standard care options like MRI or CT scans, this technique uses ultrasound enhanced with a contrast agent, providing real-time imaging that helps in better understanding the tumor's blood supply and structure. This could potentially lead to more precise treatment planning and monitoring, offering a unique advantage over existing imaging techniques.

What evidence suggests that this imaging technique is effective for soft tissue sarcoma?

Research has shown that contrast-enhanced ultrasound (CEUS) with Definity, which participants in this trial will receive, can help evaluate soft tissue sarcomas. CEUS enhances imaging accuracy by highlighting blood flow and tissue differences, aiding doctors in assessing tumor response to treatment. Studies have found that CEUS can match MRI effectiveness in evaluating tumor changes. Definity, the contrast agent used in this trial, clarifies ultrasound images, revealing tumor behavior. This makes it a potentially useful tool for planning and monitoring the effectiveness of radiation therapy.678910

Who Is on the Research Team?

KN

Kibo Nam, PhD

Principal Investigator

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Are You a Good Fit for This Trial?

This trial is for adults (18+) with confirmed soft tissue sarcoma in the trunk or limbs who are scheduled to receive radiation therapy before surgery. Participants must be able to follow study procedures and cannot join if pregnant, breastfeeding, allergic to Definity, have very large tumors not suitable for ultrasound, other active cancers needing treatment, metastatic disease, or prior radiation in the area.

Inclusion Criteria

I have been diagnosed with sarcoma in my trunk or limbs.
Provide signed and dated informed consent form
Willing to comply with all study procedures and be available for the duration of the study
See 2 more

Exclusion Criteria

Pregnancy or lactation
Known allergic reactions to any component of Definity
STS that is too large for ultrasound imaging (e.g. its short axis is larger than 10 cm at the depth of 2 cm)
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Baseline ultrasound imaging and CEUS with Definity administration

1 week
1 visit (in-person)

Neoadjuvant Radiotherapy

Participants undergo neoadjuvant radiotherapy with CEUS performed at three time points: before the first RT fraction, halfway through RT, and between the completion of RT and surgery

5 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of tumor size and RECIST response

Approximately 3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Definity

Trial Overview

The study tests whether contrast-enhanced ultrasound (CEUS) using Definity can help monitor how soft tissue sarcomas respond to pre-surgery radiation therapy. CEUS scans will be done three times during treatment and compared with CT/MRI images.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: CEUS with DefinityExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials
475
Recruited
189,000+

Citations

Contrast-enhanced ultrasound findings in soft-tissue lesions

The aim of this pilot study was to explore the potential suitability of dynamic contrast-enhanced ultrasound (DCE-US) for this purpose.

The efficacy of diagnostic imaging for superficial soft tissue ...

We seek to identify the efficacy of two of the most common forms of diagnostics in cases of superficial soft tissue masses, ultrasound and MRI, ...

Focused Ultrasound for Sarcomas: A Narrative Review

In this narrative review, we summarize the mechanisms of focused ultrasound that have been investigated for the treatment of sarcomas and highlight the results ...

Soft-Tissue Tumor Contrast Enhancement Patterns - AJR Online

OBJECTIVE. The purpose of this study was to assess and compare contrast-enhanced ultrasound and MRI patterns in the diagnosis of soft-tissue ...

Perfusion-Weighted Imaging With Dynamic Contrast ...

Dynamic contrast-enhanced MR imaging in monitoring response to isolated limb perfusion in high-grade soft tissue sarcoma: Initial results.

6.

definityimaging.com

definityimaging.com/safety

Safety Profile of DEFINITY® for Medical Imaging

DEFINITY® is demonstrated to be safe in patients with a high prevalence of cardiopulmonary disease and pulmonary hypertension5-7. Case-Based Review of Clinical ...

Application of Contrast-enhanced Ultrasound in Monitoring ...

This pilot study will evaluate the feasibility of applying CEUS as imaging guidance for planning RT and predicting RT response.

Definity - accessdata.fda.gov

WARNING: SERIOUS CARDIOPULMONARY REACTIONS. See full prescribing information for complete boxed warning. Serious cardiopulmonary reactions, including ...

Perflutren lipid microsphere (intravenous route)

Perflutren lipid microsphere injection is used during an echocardiogram to help diagnose or find problems in the heart.

How to set‐up and perform contrast‐enhanced ultrasound

Definity® is composed of perflutren (octafluoropropane) gas and a lipid shell. The combination of a microbubble and a shell is also known as a microsphere.