NCT07436364 Application of Contrast-enhanced Ultrasound in Monitoring Soft Tissue Sarcoma Response to Neoadjuvant Radiotherapy
| NCT ID | NCT07436364 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Thomas Jefferson University |
| Condition | Soft Tissue Sarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-03-23 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2026-03-23 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Kibo Nam, PhD
PRINCIPAL INVESTIGATOR
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Frequently Asked Questions
Who can join the NCT07436364 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Soft Tissue Sarcoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07436364 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07436364 currently recruiting?
Yes, NCT07436364 is actively recruiting participants. Contact the research team at Kibo.Nam@jefferson.edu for enrollment information.
Where is the NCT07436364 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT07436364 clinical trial?
NCT07436364 is sponsored by Thomas Jefferson University. The principal investigator is Kibo Nam, PhD at Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The trial plans to enroll 10 participants.