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Application of Contrast-enhanced Ultrasound in Monitoring Soft Tissue Sarcoma Response to Neoadjuvant Radiotherapy

RecruitingEARLY Phase 1Ages 18 Years - anyAllThomas Jefferson University
NCT07436364 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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)

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📋 Eligibility rules (as published)
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
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What it tests

  • Definity
  • Contrast-Enhanced Ultrasound
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Where

1 site
Thomas Jefferson University Hospital
Philadelphia, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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