Recruiting
Early Phase 1

CEUS

Sponsor:

Thomas Jefferson University

Code:

NCT07436364

Conditions

Soft Tissue Sarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Definity

Contrast-Enhanced Ultrasound

Study Details

Brief 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.

Conditions

Soft Tissue Sarcoma

Study ID

NCT07436364

Start date

Mar 23, 2026

Status verified date

Apr, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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 measure

  • Success of US-CT/MRI fusion [ Time Frame: From Baseline to Post-Radiotherapy prior to Surgery, Approximately 3 months ]

Central Contacts and Locations

Central contacts

Kibo Nam, PhD

215-955-6261Kibo.Nam@jefferson.edu

Locations

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Kibo Nam, PhD

215-955-6261Kibo.Nam@jefferson.edu

Principal Investigator:

Kibo Nam, PhD

More Information

Sponsor

Thomas Jefferson University

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Keywords

  • Sarcoma
  • CEUS
  • Ultrasound Imaging
  • Definity
  • ultrasound contrast agent
  • Subharmonic-aided Pressure Estimation
  • SHAPE
  • tumor vascularity
  • CT
  • MRI
  • on-site cone-beam CT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2026-04-14.