Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT07436364

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

Led by Thomas Jefferson University · Updated on 2026-04-14

10

Participants Needed

1

Research Sites

57 weeks

Total Duration

On this page

AI-Summary

What this Trial 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. 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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, aged 18 years or older
  • Patients with pathologically confirmed soft tissue sarcoma in the trunk or extremities
  • Scheduled for neoadjuvant radiotherapy for soft tissue sarcoma (standard or hypofractionation schedules permitted)
Not Eligible

You will not qualify if you...

  • Pregnancy or lactation
  • Known allergic reactions to any component of Definity
  • Soft tissue sarcoma too large for ultrasound imaging (short axis larger than 10 cm at 2 cm depth)
  • Presence of other primary cancers requiring systemic treatment
  • Metastatic disease at presentation
  • Prior radiotherapy to the area

AI-Screening

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Trial Site Locations

Total: 1 location

1

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

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Research Team

K

Kibo Nam, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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