Soft Tissue SarcomaEarly Phase 1NCT07436364
Application of Contrast-enhanced Ultrasound in Monitoring Soft Tissue Sarcoma Response to Neoadjuvant Radiotherapy
A Early Phase 1 study testing Definity and Contrast-Enhanced Ultrasound in people with Soft Tissue Sarcoma, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Definity and Contrast-Enhanced Ultrasound
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2026to May 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Kibo Nam, PhD, 215-955-6261, Kibo.Nam@jefferson.edu
Kibo Nam, PhD
About this study
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.
Read the detailed description
This is an open-label, non-randomized, human trial that will be conducted at one clinical site, Thomas Jefferson University. Our subjects will be patients with localized STS scheduled for neoadjuvant RT based upon the recommendations of our multidisciplinary sarcoma tumor board.
All subjects will have an unenhanced (baseline) conventional US followed by CEUS study with infusion of ultrasound contrast agent (Definity; Lantheus Medical Imaging). The investigators will collect the study data at three time points: 1) prior to the first RT fraction, 2) middle of RT (e.g., any day on 3rd week of 5 week-long RT), and 3) between the completion of RT and surgery.
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.
On the study visit, the investigators first perform conventional US including Doppler imaging using a C2-9VN probe (with embedded electromagnetic sensors) on Loqiq E10 (GE HealthCare) to locate the whole tumor and select the planes for fusion. The US scanner has dedicated fusion software, and the investigators will load the pre-obtained CT/MRI (most recent CT/MRI by standard of care) on US scanner and fuse it with real-time US by selecting references points under the magnetic field created by an electromagnetic transmitter near a subject. Once the fusion is done (if the fusion fails or unsatisfactory, the investigators will perform CEUS alone), the investigators will start the infusion UCA, Definity (3 ml of Definity suspended in 50 ml saline) 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. The dosage was selected based on our previous work in monitoring breast tumor IFP in humans. Conventional CEUS images will be collected as 2D movie clips sweeping over 3D tumor volume during infusion. Then, the investigators will turn on SHAPE mode. The investigators will determine the optimum SHAPE settings (where the subharmonic signal changed the most, which will vary among subjects) for each subject and infusion will be stopped during this process. With restarting the infusion, the SHAPE data will be collected with individually determined acoustic power, which allows us to compare the pressure between subjects independently of an operator and other imaging settings. Another set of SHAPE data will be acquired at the same acoustic output power setting with no UCA after roughly 5 minutes (to allow for clearance of bubbles).
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Definity, Contrast-Enhanced Ultrasound
- Keywords
- Sarcoma, CEUS, Ultrasound Imaging, Definity, ultrasound contrast agent, Subharmonic-aided Pressure Estimation, SHAPE, tumor vascularity, CT, MRI, on-site cone-beam CT
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DefinityDrug
Also called Perflutren Lipid Microsphere, Definity RT
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.
Contrast-Enhanced UltrasoundDiagnostic test
Also called CEUS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Definity; Diagnostic Test: Contrast-Enhanced Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From Baseline to Post-Radiotherapy prior to Surgery, Approximately 3 months
Secondary outcomes (3)
Evaluation of Tumor Size
The tumor area/volume with/without enhancement from CEUS will be compared with those from CTs or MRIs using data plots; by computing Pearson's correlation coefficients; and by computing and presenting in a table their respective means ± standard deviations as well as the respective means and 95% confidence intervals for the differences between CEUS and CT or MRI modalities.
The investigators will report the mean ± standard deviation from CEUS and CT/MRI and the difference between two imaging modality in mean ± standard deviation.
Measured: From Baseline to Post-Radiotherapy prior to Surgery, Approximately 3 months
Evaluation of RECIST Response
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by standard of care imaging (e.g., CT/MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. The investigators will evaluate the RECIST response assessed by standard of care imaging is consistent with the RECEIST response assessed by CEUS.
Measured: Prior to Surgery
Correlation with Histological Outcome After Surgery
The residual tumor area/volume quantified using 2D conventional CEUS clips will be also compared with histology outcomes (necrosis and viable tumor areas) using correlation coefficients. The investigators will evaluate if the viable/non-viable lesions identified by histology are correlated with the lesion vascularity and pressure quantified from CEUS.
Measured: After Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start23 Mar 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kibo Nam, PhD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07436364
- Sponsor's protocol ID
- iRISID-2025-1257
- Other IDs
- JT 46327
- Status last verified
- Apr 2026
- First submitted
- 18 Feb 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Contrast-enhanced Ultrasound in Monitoring Soft Tissue Sarcoma Response to Neoadjuvant Radiotherapy
- ClinicalTrials.gov ID
- NCT07436364
- Acronym / sponsor ID
- iRISID-2025-1257
- Conditions
- Soft Tissue Sarcoma
- Keywords
- Sarcoma, CEUS, Ultrasound Imaging, Definity, ultrasound contrast agent, Subharmonic-aided Pressure Estimation, SHAPE, tumor vascularity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, non-randomized, human trial that will be conducted at one clinical site, Thomas Jefferson University. Our subjects will be patients with localized STS scheduled for neoadjuvant RT based upon the recommendations of our multidisciplinary sarcoma tumor board.
All subjects will have an unenhanced (baseline) conventional US followed by CEUS study with infusion of ultrasound contrast agent (Definity; Lantheus Medical Imaging). The investigators will collect the study data at three time points: 1) prior to the first RT fraction, 2) middle of RT (e.g., any day on 3rd week of 5 week-long RT), and 3) between the completion of RT and surgery.
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.
On the study visit, the investigators first perform conventional US including Doppler imaging using a C2-9VN probe (with embedded electromagnetic sensors) on Loqiq E10 (GE HealthCare) to locate the whole tumor and select the planes for fusion. The US scanner has dedicated fusion software, and the investigators will load the pre-obtained CT/MRI (most recent CT/MRI by standard of care) on US scanner and fuse it with real-time US by selecting references points under the magnetic field created by an electromagnetic transmitter near a subject. Once the fusion is done (if the fusion fails or unsatisfactory, the investigators will perform CEUS alone), the investigators will start the infusion UCA, Definity (3 ml of Definity suspended in 50 ml saline) 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. The dosage was selected based on our previous work in monitoring breast tumor IFP in humans. Conventional CEUS images will be collected as 2D movie clips sweeping over 3D tumor volume during infusion. Then, the investigators will turn on SHAPE mode. The investigators will determine the optimum SHAPE settings (where the subharmonic signal changed the most, which will vary among subjects) for each subject and infusion will be stopped during this process. With restarting the infusion, the SHAPE data will be collected with individually determined acoustic power, which allows us to compare the pressure between subjects independently of an operator and other imaging settings. Another set of SHAPE data will be acquired at the same acoustic output power setting with no UCA after roughly 5 minutes (to allow for clearance of bubbles).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CEUS with Definity | Experimental | Drug: Definity, Diagnostic Test: Contrast-Enhanced UltrasoundPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
- o Both standard and hypofractionation schedules are permitted.
Key exclusion criteria (7 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DefinityAlso: Perflutren Lipid Microsphere, Definity RTDefinity 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. | Drug | CEUS with Definity |
| Contrast-Enhanced UltrasoundAlso: CEUSContrast-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. | Diagnostic test | CEUS with Definity |
Primary outcome
Success of US-CT/MRI fusion
Time frame: From Baseline to Post-Radiotherapy prior to Surgery, Approximately 3 months
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.
3 secondary outcomes
Evaluation of Tumor Size
Time frame: From Baseline to Post-Radiotherapy prior to Surgery, Approximately 3 months
Evaluation of RECIST Response
Time frame: Prior to Surgery
Correlation with Histological Outcome After Surgery
Time frame: After Surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kibo Nam, PhD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Definity and Contrast-Enhanced Ultrasound in people with Soft Tissue Sarcoma, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kibo Nam, PhD (215-955-6261, Kibo.Nam@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of US-CT/MRI fusion (time frame: From Baseline to Post-Radiotherapy prior to Surgery, Approximately 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.