Adult Soft Tissue SarcomaEarly Phase 1NCT02384473
Real-Time Contrast-Enhanced Ultrasonography and Shear Wave Elastography in Predicting Treatment Response in Patients With Soft Tissue Sarcoma
A Early Phase 1 study testing Real-Time CEUS, SWE and Definity Suspension for Injection in people with Adult Soft Tissue Sarcoma and Bone Sarcoma, run by University of Southern California at 1 site in United States.
Trial summary
This pilot clinical trial studies real-time contrast-enhanced ultrasonography and shear wave elastography in predicting treatment response in patients with soft tissue sarcomas. Ultrasonography and elastography are diagnostic imaging tests that use sound waves to make pictures of the body without using radiation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Soft Tissue Sarcoma, Bone Sarcoma, Retroperitoneal Sarcoma
- What is being tested?
- Real-Time CEUS, SWE and Definity Suspension for Injection
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Dec 2014to 19 Jan 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- Patients with biopsy and/or conventional imaging (CT/MRI) proven STS or bone sarcoma with a measurable soft tissue component; these include patients with extremity, retroperitoneal, chest wall, or head and neck primary sarcomas
- Patients who are potential candidates to receive neoadjuvant therapy with either chemotherapy alone, radiation alone, immunotherapy alone or combined treatment with any of these modalities. If on therapy, patients in whom a new treatment protocol or modality is being considered.
- Patients competent to sign study specific informed consent
- Patients willing to comply with protocol requirements
Who cannot join
- Patients who are pregnant
- Patients who have a known cardiac shunt or pulmonary hypertension
- Patients with any known hypersensitivity to perflutren agent
- Patients who cannot consent for themselves
Trial locations and contacts
1 site in 1 country.
United States1 site
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
About this study
Official title: Real-Time Contrast Enhanced Ultrasound and Ultrasound-Based Elastography: Novel Quantitative Imaging Techniques for Early Therapy Response Assessment in Sarcomas
This pilot clinical trial studies real-time contrast-enhanced ultrasonography and shear wave elastography in predicting treatment response in patients with soft tissue sarcomas. Ultrasonography and elastography are diagnostic imaging tests that use sound waves to make pictures of the body without using radiation (x-rays). Real-time contrast-enhanced ultrasonography and shear wave elastography may help measure a patient's response to treatment given before surgery in patients with soft tissue sarcoma.
Read the detailed description
PRIMARY OBJECTIVES:
- To investigate whether two different radiologists can reliably interpret the following quantitative criteria regarding the maximally enhancing portion of a soft tissue sarcoma (STS), on sequential contrast-enhanced ultrasound (CEUS) exams performed before, during, and after neoadjuvant chemotherapy (NAC): change in peak enhancement (decibels), change in slope of enhancement curve, and change in area under the curve.
II. To evaluate CEUS as a potential early response assessment biomarker by comparing the CEUS rating result to computed tomography (CT)/magnetic resonance imaging (MRI) rating results. (Exploratory) III. To examine the agreement between CEUS versus CT/MRI determined treatment response within each radiologist rater. (Exploratory) IV. To examine the agreement between CEUS versus CT/MRI determined treatment response based on the consensus rating result from the two radiologist raters. (Exploratory) V. To explore potential quantitative biomarker from all possible parameters that can be extracted from CEUS data for assessing an early treatment response to neoadjuvant therapy (NAT) in sarcoma using receiver operating characteristic (ROC) curve when predicting radiologists rated binary outcome: responders versus non-responders. (Exploratory) VI. To collect preliminary data for shear wave elastography (SWE) in the same patient population. (Exploratory)
OUTLINE:
Patients undergo real-time CEUS and SWE at baseline, 6 weeks after initiation of neoadjuvant therapy, and 9 weeks after initiation of neoadjuvant therapy (prior to surgery).
After completion of study, patients are followed up at 24 hours.
- Being tested
- Real-Time CEUS, SWE, Definity Suspension for Injection, Philips Shear Wave Elastography
- Medical subject headings
- Sarcoma, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-Time CEUSProcedure or surgery
Undergo real-time CEUS
SWEProcedure or surgery
Also called Shear Wave Elastography
Undergo SWE
Definity Suspension for InjectionDrug
Also called Perflutren Lipid Microsphere
Participant will receive contrast agent by intravenous administration
Philips Shear Wave ElastographyDevice
Also called Shear Wave Elagstography
Type of equipment used for SWE
| Study group | Role | What they receive |
|---|---|---|
| Real-time CEUS and SWE | Experimental | Patients undergo real-time CEUS and SWE at baseline, 6 weeks after initiation of neoadjuvant therapy, and 9 weeks after initiation of neoadjuvant therapy (prior to surgery). Receives: Procedure: Real-Time CEUS; Procedure: SWE; Drug: Definity Suspension for Injection; Device: Philips Shear Wave Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-reader agreement for sequential contrast-enhanced ultra sound for evaluating treatment response as determined by kappa coefficient
Kappa coefficient will be used. Reviewer 1 will first rate the treatment response followed by reviewer 2. Reviewer 2 will be blinded to the rating of reviewer 1.
Measured: Up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study start24 Dec 2014
- Primary completion19 Jan 2024
- Study completion19 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mittul Gulati, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384473
- Sponsor's protocol ID
- 11S-14-1
- Other IDs
- NCI-2014-02579, HS-14-00792, 11S-14-1, P30CA014089
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2015
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Contrast Enhanced Ultrasound and Ultrasound-Based Elastography: Novel Quantitative Imaging Techniques for Early Therapy Response Assessment in Sarcomas
- ClinicalTrials.gov ID
- NCT02384473
- Acronym / sponsor ID
- 11S-14-1
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Dec 2014 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 10 Mar 2015 (estimated)
- 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 clinical trial studies real-time contrast-enhanced ultrasonography and shear wave elastography in predicting treatment response in patients with soft tissue sarcomas. Ultrasonography and elastography are diagnostic imaging tests that use sound waves to make pictures of the body without using radiation (x-rays). Real-time contrast-enhanced ultrasonography and shear wave elastography may help measure a patient's response to treatment given before surgery in patients with soft tissue sarcoma.
Detailed description
PRIMARY OBJECTIVES:
- To investigate whether two different radiologists can reliably interpret the following quantitative criteria regarding the maximally enhancing portion of a soft tissue sarcoma (STS), on sequential contrast-enhanced ultrasound (CEUS) exams performed before, during, and after neoadjuvant chemotherapy (NAC): change in peak enhancement (decibels), change in slope of enhancement curve, and change in area under the curve.
II. To evaluate CEUS as a potential early response assessment biomarker by comparing the CEUS rating result to computed tomography (CT)/magnetic resonance imaging (MRI) rating results. (Exploratory) III. To examine the agreement between CEUS versus CT/MRI determined treatment response within each radiologist rater. (Exploratory) IV. To examine the agreement between CEUS versus CT/MRI determined treatment response based on the consensus rating result from the two radiologist raters. (Exploratory) V. To explore potential quantitative biomarker from all possible parameters that can be extracted from CEUS data for assessing an early treatment response to neoadjuvant therapy (NAT) in sarcoma using receiver operating characteristic (ROC) curve when predicting radiologists rated binary outcome: responders versus non-responders. (Exploratory) VI. To collect preliminary data for shear wave elastography (SWE) in the same patient population. (Exploratory)
OUTLINE:
Patients undergo real-time CEUS and SWE at baseline, 6 weeks after initiation of neoadjuvant therapy, and 9 weeks after initiation of neoadjuvant therapy (prior to surgery).
After completion of study, patients are followed up at 24 hours.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Real-time CEUS and SWE | Experimental | Procedure: Real-Time CEUS, Procedure: SWE, Drug: Definity Suspension for Injection, Device: Philips Shear Wave ElastographyPatients undergo real-time CEUS and SWE at baseline, 6 weeks after initiation of neoadjuvant therapy, and 9 weeks after initiation of neoadjuvant therapy (prior to surgery). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with biopsy and/or conventional imaging (CT/MRI) proven STS or bone sarcoma with a measurable soft tissue component; these include patients with extremity, retroperitoneal, chest wall, or head and neck primary sarcomas
- Patients who are potential candidates to receive neoadjuvant therapy with either chemotherapy alone, radiation alone, immunotherapy alone or combined treatment with any of these modalities. If on therapy, patients in whom a new treatment protocol or modality is being considered.
- Patients competent to sign study specific informed consent
- Patients willing to comply with protocol requirements
Key exclusion criteria (4 listed)
- Patients who are pregnant
- Patients who have a known cardiac shunt or pulmonary hypertension
- Patients with any known hypersensitivity to perflutren agent
- Patients who cannot consent for themselves
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 |
|---|---|---|
| Real-Time CEUSUndergo real-time CEUS | Procedure or surgery | Real-time CEUS and SWE |
| SWEAlso: Shear Wave ElastographyUndergo SWE | Procedure or surgery | Real-time CEUS and SWE |
| Definity Suspension for InjectionAlso: Perflutren Lipid MicrosphereParticipant will receive contrast agent by intravenous administration | Drug | Real-time CEUS and SWE |
| Philips Shear Wave ElastographyAlso: Shear Wave ElagstographyType of equipment used for SWE | Device | Real-time CEUS and SWE |
Primary outcome
Inter-reader agreement for sequential contrast-enhanced ultra sound for evaluating treatment response as determined by kappa coefficient
Time frame: Up to 9 weeks
Kappa coefficient will be used. Reviewer 1 will first rate the treatment response followed by reviewer 2. Reviewer 2 will be blinded to the rating of reviewer 1.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
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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. This study is not recruiting at the moment.
Mittul Gulati principal investigator
University of Southern California
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 Real-Time CEUS, SWE and Definity Suspension for Injection in people with Adult Soft Tissue Sarcoma and Bone Sarcoma, run by University of Southern California 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 23 Jan 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-reader agreement for sequential contrast-enhanced ultra sound for evaluating treatment response as determined by kappa coefficient (time frame: Up to 9 weeks). 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 23 Jan 2024.