Adult Soft Tissue Sarcoma Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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

Locations
United States
Pennsylvania
Thomas Jefferson University Hospital
RECRUITING
Philadelphia
Contact Information
Primary
Kibo Nam, PhD
Kibo.Nam@jefferson.edu
215-955-6261
Time Frame
Start Date: 2026-03-23
Estimated Completion Date: 2027-05
Participants
Target number of participants: 10
Treatments
Experimental: CEUS with Definity
Patients will first undergo baseline ultrasound imaging over the whole tumor and then will receive an administration of ultrasound contrast agent. The ultrasound contrast administration will be an intravenous infusion of 2 vials of Definity/50ml saline 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 18-22 gauge angiocatheter. During the contrast infusion, CEUS data will be collected.
Related Therapeutic Areas
Sponsors
Leads: Thomas Jefferson University

This content was sourced from clinicaltrials.gov