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

NCT07436364 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: iRISID-2025-1257JT 46327
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Success of US-CT/MRI fusion

  It will be treated as a binary outcome and summarized with a proportion and presented with a Clopper-Pearson exact 95% confidence interval at the visit level and at the patient level (where success at every visit relates success for the patient). The investigators will evaluate the US-CT/MRI fusion qualitatively (by a radiologist) either Success or Fail at each time point (3 time points in total). The investigators will consider Success for a patient if more than 50% success rate from three time points.

  From Baseline to Post-Radiotherapy prior to Surgery, Approximately 3 months

Secondary Outcomes (3)

• Evaluation of Tumor Size

  From Baseline to Post-Radiotherapy prior to Surgery, Approximately 3 months

• Evaluation of RECIST Response

  Prior to Surgery

• Correlation with Histological Outcome After Surgery

  After Surgery

Study Arms (1)

CEUS with Definity

EXPERIMENTAL

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.

Drug: Definity; Diagnostic Test: Contrast-Enhanced Ultrasound

Interventions

Definity DRUG

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.

Also known as: Perflutren Lipid Microsphere, Definity RT

CEUS with Definity

Contrast-Enhanced Ultrasound DIAGNOSTIC_TEST

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.

Also known as: CEUS

CEUS with Definity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Sarcoma

Interventions

perflutren

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Kibo Nam, PhD

  Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kibo Nam, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 27, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)