Contrast-enhanced ultrasound to monitor soft tissue sarcoma during neoadjuvant radiation

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

This pilot will try contrast-enhanced ultrasound with Definity in adults with localized soft tissue sarcoma who are receiving pre-surgery radiation to see if it can guide radiation planning and predict treatment response.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Thomas Jefferson University (other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT07436364 on ClinicalTrials.gov

What this trial studies

This early-phase, open-label pilot at a single center will perform contrast-enhanced ultrasound (CEUS) with Definity at three time points: before the first radiation fraction, mid-course, and after completion but prior to surgery. Investigators will attempt to fuse real-time ultrasound with pre-existing CT/MRI or on-site cone-beam CT to map the entire tumor and collect panoramic 2D CEUS images that approximate 3D coverage. If fusion is not feasible they will perform side-by-side imaging with CT/MRI and quantify contrast-enhanced vascular area/volume versus B-mode tumor size while analyzing subharmonic amplitudes and perfusion metrics over time. The aim is to test feasibility of fusion imaging and determine whether CEUS vascular and pressure signals reflect or predict radiotherapy response in trunk and extremity sarcomas.

Who should consider this trial

Good fit: Adults (≥18 years) with pathologically confirmed localized trunk or extremity soft tissue sarcoma who are scheduled for neoadjuvant radiotherapy and can receive intravenous ultrasound contrast are ideal candidates.

Not a fit: Patients who are pregnant or lactating, allergic to Definity, have tumors too large for ultrasound imaging (short axis >10 cm at 2 cm depth), or require treatment for other active primary cancers are unlikely to benefit.

Why it matters

Potential benefit: If successful, this approach could help personalize radiation planning and identify responders earlier so treatment can be adapted or intensified.

How similar studies have performed: CEUS has shown promise for measuring tumor vascularity in other cancers, but using CEUS with CT/MRI fusion to predict radiotherapy response in soft tissue sarcoma is largely novel and unproven.

Eligibility criteria

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 this trial is running

Philadelphia, Pennsylvania

• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Kibo Nam, PhD — Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
• Study coordinator: Kibo Nam, PhD

Conditions: Soft Tissue Sarcoma, Sarcoma, CEUS, Ultrasound Imaging, Definity, ultrasound contrast agent, Subharmonic-aided Pressure Estimation, SHAPE