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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: Kibo.Nam@jefferson.edu
• Phone: 215-955-6261

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• 68Ga-HX01 PET/CT Imaging in Soft Tissue Sarcoma patients

  This study tests whether a 68Ga-HX01 injection can help PET/CT imaging better characterize soft tissue sarcoma in adults who have exhausted standard treatments or have no good options.

  Recruiting Phase 2 Hexin (Suzhou) Pharmaceutical Technology Co., Ltd · Wuhan, Hubei · NCT07920835

• Zemetostat plus Anlotinib for SWI/SNF-deficient Head and Neck Soft Tissue Sarcoma

  This trial tests whether zemetostat plus anlotinib can help people with recurrent or metastatic head-and-neck soft tissue sarcoma that has SWI/SNF complex deficiency after standard therapy fails.

  Recruiting Phase 2 Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Shanghai, Shanghai Municipality · NCT07917949

• Entinostat for pediatric soft tissue sarcoma with PAX abnormalities

  This study tests entinostat, alone or with chemotherapy, in children whose soft tissue sarcomas have PAX-family gene abnormalities to see if it can help shrink tumors or slow progression.

  Recruiting Phase 1 Beijing Tongren Hospital · Beijing, Beijing Municipality · NCT07888114

• Methionine-Reduced Diet in Solid Tumors (early-phase)

  A small pilot study will test whether a methionine-reduced diet can change blood levels in adults with various solid tumors who are receiving standard cancer therapy.

  Recruiting Early Phase 1 University of California, Irvine · Orange, California · NCT07628634

• Preoperative Immunonutrition for bone and soft tissue sarcoma patients

  This study tests whether a short course of an oral nutrition supplement before surgery can help patients with bone or soft tissue sarcomas recover better after major tumor-related surgery.

  Recruiting St. Anne's University Hospital Brno, Czech Republic · Brno · NCT07609329

• Adaptive Proton Therapy for Pediatric Solid Tumors and Hodgkin Lymphoma

  This study tests a regular imaging approach to see if proton therapy plans for children with solid tumors or Hodgkin lymphoma should be updated during treatment.

  Recruiting St. Jude Children's Research Hospital · Memphis, Tennessee · NCT07514819

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.