NCT07436364 · Thomas Jefferson University
Application of Contrast-enhanced Ultrasound in Monitoring Soft Tissue Sarcoma Response to Neoadjuvant Radiotherapy
What this study is about
This pilot study will evaluate the feasibility of applying CEUS as imaging guidance for planning RT and predicting RT response. The investigators will determine if US-CT/MRI fusion is feasible and if tumor vascularity and pressure from CEUS can be used to reflect/predict the RT response.
View original scientific description
This pilot study will evaluate the feasibility of applying CEUS as imaging guidance for planning RT and predicting RT response. The investigators will determine if US-CT/MRI fusion is feasible and if tumor vascularity and pressure from CEUS can be used to reflect/predict the RT response. The investigators will perform CEUS three times: before the first neoadjuvant RT fraction, halfway through RT, and between the completion of RT and surgery. The fusion will be performed using previously acquired CT/MRI or on-site cone-beam CT with Bmode US. Once the fusion is successful, CEUS will be performed and panoramic 2D images (mimicking 3D) will be collected for the whole tumor. If the fusion is not feasible or successful, the investigators will perform CEUS side by side with CT/MRI and collect images. The investigators will quantify tumoral vascularity comparing Bmode area/volume (total tumor) and contrast-enhanced area/volume (vascular region) at each time point. Subharmonic amplitudes in the tumor area/volume will be quantified to estimate tumoral pressure (known to be the same level as interstitial fluid pressure (IFP)). Quantified vascularity and pressure at each time point will be compared with the tumor size change at later study points as well as the histological outcome after the surgery.
Interventions
DRUG
Definity
Definity will be administered as an IV infusion via a peripheral vein (preferably the antecubital vein), with infusion rates of 4 to 10 ml/min (titrated to effect) through an 18 to 22 gauge angio-catheter.
DIAGNOSTIC_TEST
Contrast-Enhanced Ultrasound
Contrast-enhanced ultrasound (CEUS) imaging will be performed after baseline ultrasound imaging of the tumor. During intravenous infusion of ultrasound contrast agent, CEUS data will be collected as 2D movie clips sweeping over the tumor volume. CEUS imaging will be performed at three study timepoints: prior to the first radiotherapy fraction, during radiotherapy, and after completion of radiotherapy prior to surgery.
Primary outcome measures
Success of US-CT/MRI fusion
Time frame: From Baseline to Post-Radiotherapy prior to Surgery, Approximately 3 months
It will be treated as a binary outcome and summarized with a proportion and presented with a Clopper-Pearson exact 95% confidence interval at the visit level and at the patient level (where success at every visit relates success for the patient). The investigators will evaluate the US-CT/MRI fusion qualitatively (by a radiologist) either Success or Fail at each time point (3 time points in total). The investigators will consider Success for a patient if more than 50% success rate from three time points.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
- Provide signed and dated informed consent form
- Willing to comply with all study procedures and be available for the duration of the study
- Male or female, Male or female, aged ≥18 years of age
- Patients with pathologically confirmed STS (Trunk and extremity sarcoma only)
- Scheduled for neoadjuvant RT for STS o Both standard and hypofractionation schedules are permitted.
- Willing to comply with all study procedures and be available for the duration of the study
Exclusion criteria
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy or lactation
- Known allergic reactions to any component of Definity
- Has STS that is too large for ultrasound imaging (e.g. its short axis is larger than 10 cm at the depth of 2 cm)
- Has other primary cancers requiring systemic treatment.
- Has metastatic disease at presentation
- Had prior RT to the area
Where
- Philadelphia, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 14, 2026 · Source of record for eligibility and locations