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NCT07436364 · ClinicalTrials.gov registry record · Early Phase 1
Application of Contrast-enhanced Ultrasound in Monitoring Soft Tissue Sarcoma Response to Neoadjuvant Radiotherapy
A Early Phase 1 study, sponsored by Thomas Jefferson University.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
NCT07436364 is a Early Phase 1 study that is actively recruiting participants, run by Thomas Jefferson University. The registered enrollment target is 10 participants.
The verdict
NCT07436364, a Early Phase 1 study, is actively recruiting participants, sponsored by Thomas Jefferson University.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
Study 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.
Interventions
- DRUG Definity
- DIAGNOSTIC_TEST Contrast-Enhanced Ultrasound
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2026-03-23 |
| Est. Completion | 2027-05 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07436364
The ClinicalTrials.gov registry entry for NCT07436364 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Definity is the first listed.
NCT07436364 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07436364 about?
NCT07436364 is a clinical study titled "Application of Contrast-enhanced Ultrasound in Monitoring Soft Tissue Sarcoma Response to Neoadjuvant Radiotherapy". 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 invest...
What is the current status of trial NCT07436364?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2026-03-23. Estimated completion is 2027-05.
What interventions are being tested in trial NCT07436364?
The interventions under investigation include: Definity (DRUG), Contrast-Enhanced Ultrasound (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT07436364?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
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