Breast CancerPhase 1NCT02067884
Contrast Enhanced Ultrasound and Shear Wave Elastography in Measuring Response in Patients With Breast Cancer Receiving Chemotherapy Before Surgery
A Phase 1 study testing dynamic contrast-enhanced ultrasound imaging, shear wave elastography and Definity, (Lipid Microspheres) Intravenous Suspension in people with Breast Cancer, run by University of Southern California at 1 site in United States.
Trial summary
This pilot clinical trial studies contrast enhanced ultrasound and shear wave elastography in measuring response in patients with breast cancer receiving chemotherapy before surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- dynamic contrast-enhanced ultrasound imaging, shear wave elastography and Definity, (Lipid Microspheres) Intravenous Suspension
- 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
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2013to 25 Sep 2016
- Phase
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with histologically confirmed breast cancer (by core needle biopsy)
- Women with >= 2 cm clinically or radiologically measureable breast cancer
- Women scheduled to receive neoadjuvant chemotherapy as part of their treatment plan
- Women competent to sign study specific written Informed Consent
- Women willing to comply with protocol requirements
Who cannot join
- Women who are pregnant
- Women who have undergone open surgical (excisional) biopsy for breast cancer diagnosis
- Women who have had a prior history of breast cancer in the same breast
- Women with known cardiac shunt, pulmonary hypertension or hypersensitivity to perflutren agent
- Women 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 Techniques in Assessment of Treatment Response to Neoadjuvant Chemotherapy for Breast Cancer
This pilot clinical trial studies contrast enhanced ultrasound and shear wave elastography in measuring response in patients with breast cancer receiving chemotherapy before surgery. New imaging procedures, such as contrast enhanced ultrasound and shear wave elastography, may predict treatment response earlier and more accurately than contrast enhanced magnetic resonance imaging.
Read the detailed description
PRIMARY OBJECTIVES:
- To establish a quantitative prediction rule for accurate and early prediction of the pathologic tumor response assessed post-surgery, using the change of contrast enhanced ultrasound (CEUS) assessed tumor size and perfusion characteristics before (baseline) and 2-3 weeks following initiation of neoadjuvant chemotherapy (NAC).
II. To assess the agreement between CEUS based classification rule and pathologically determined treatment response (baseline versus pre-surgical scan).
III. To establish a quantitative prediction rule for accurate and early prediction of the pathologic tumor response assessed post-surgery, using the change in propagation velocity of a shear mechanical wave in tissue before (baseline) and 2-3 weeks following initiation of NAC.
IV. To assess the agreement between shear wave elastography (SWE) based classification rule and pathologically determined treatment response (baseline versus pre-surgical scan).
SECONDARY OBJECTIVES:
- To explore the role of combined CEUS + SWE features obtained at early treatment phase (2-3 weeks following initiation of NAC), in accurately predicting the pathologically determined tumor response.
II. To investigate the agreement in assessment of therapy response to NAC between CEUS versus contrast enhanced magnetic resonance imaging (CE MRI) and SWE versus CE MRI for baseline versus pre-surgery scan and to identify discordant cases using scatter plot and contingency tables.
OUTLINE:
Patients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at baseline, 2-3 weeks after initiation of chemotherapy, and before surgery.
- Conditions
- Breast Cancer
- Being tested
- dynamic contrast-enhanced ultrasound imaging, shear wave elastography, Definity, (Lipid Microspheres) Intravenous Suspension, Philips Shear Wave Elastography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamic contrast-enhanced ultrasound imagingProcedure or surgery
Also called DCE-USI
Undergo CEUS
shear wave elastographyProcedure or surgery
Also called SWE
Undergo SWE
Definity, (Lipid Microspheres) Intravenous SuspensionDrug
Also called Perflutren Lipid Microsphere
Participant will receive contrast agent by intravenous administration
Philips Shear Wave ElastographyDevice
Also called Shear Wave Elastography
Equipment used for SWE
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (CEUS, SWE) | Experimental | Patients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at baseline, 2-3 weeks after initiation of chemotherapy, and before surgery. Receives: Procedure: dynamic contrast-enhanced ultrasound imaging; Procedure: shear wave elastography; Drug: Definity, (Lipid Microspheres) Intravenous Suspension; Device: Philips Shear Wave Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Model predicted treatment response for CEUS and SWE
Weighted Kappa will be used to assess the agreement.
Measured: Up to 1 year
Pathologically determined treatment response for CEUS and SWE
Weighted Kappa will be used to assess the agreement.
Measured: Up to 1 year
Secondary outcomes (2)
Treatment response predicted by novel ultrasound techniques
Weighted Kappa will be used to assess the agreement. Scatter plots and contingency tables will be used to identify discordant cases between US techniques and CE MRI.
Measured: Up to 1 year
Treatment response predicted by CE MRI
Weighted Kappa will be used to assess the agreement. Scatter plots and contingency tables will be used to identify discordant cases between US techniques and CE MRI.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study start19 Dec 2013
- Primary completion25 Sep 2016
- Study completion25 Sep 2016
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), L K Whittier Foundation
- Responsible party
- Sponsor
- Investigators
- Linda Hovanessian-Larsen, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067884
- Sponsor's protocol ID
- 1B-13-8
- Other IDs
- NCI-2014-00085, 1B-13-8, P30CA014089
- Status last verified
- Jan 2019
- First submitted
- 4 Feb 2014
- Last updated
- 25 Jan 2019
- 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 25 Jan 2019. 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 Techniques in Assessment of Treatment Response to Neoadjuvant Chemotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT02067884
- Acronym / sponsor ID
- 1B-13-8
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), L K Whittier Foundation
- Study start
- 19 Dec 2013 (actual)
- Primary completion
- 25 Sep 2016 (actual)
- Study completion
- 25 Sep 2016 (actual)
- First posted
- 20 Feb 2014 (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 contrast enhanced ultrasound and shear wave elastography in measuring response in patients with breast cancer receiving chemotherapy before surgery. New imaging procedures, such as contrast enhanced ultrasound and shear wave elastography, may predict treatment response earlier and more accurately than contrast enhanced magnetic resonance imaging.
Detailed description
PRIMARY OBJECTIVES:
- To establish a quantitative prediction rule for accurate and early prediction of the pathologic tumor response assessed post-surgery, using the change of contrast enhanced ultrasound (CEUS) assessed tumor size and perfusion characteristics before (baseline) and 2-3 weeks following initiation of neoadjuvant chemotherapy (NAC).
II. To assess the agreement between CEUS based classification rule and pathologically determined treatment response (baseline versus pre-surgical scan).
III. To establish a quantitative prediction rule for accurate and early prediction of the pathologic tumor response assessed post-surgery, using the change in propagation velocity of a shear mechanical wave in tissue before (baseline) and 2-3 weeks following initiation of NAC.
IV. To assess the agreement between shear wave elastography (SWE) based classification rule and pathologically determined treatment response (baseline versus pre-surgical scan).
SECONDARY OBJECTIVES:
- To explore the role of combined CEUS + SWE features obtained at early treatment phase (2-3 weeks following initiation of NAC), in accurately predicting the pathologically determined tumor response.
II. To investigate the agreement in assessment of therapy response to NAC between CEUS versus contrast enhanced magnetic resonance imaging (CE MRI) and SWE versus CE MRI for baseline versus pre-surgery scan and to identify discordant cases using scatter plot and contingency tables.
OUTLINE:
Patients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at baseline, 2-3 weeks after initiation of chemotherapy, and before surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (CEUS, SWE) | Experimental | Procedure: dynamic contrast-enhanced ultrasound imaging, Procedure: shear wave elastography, Drug: Definity, (Lipid Microspheres) Intravenous Suspension, Device: Philips Shear Wave ElastographyPatients undergo dynamic contrast-enhanced ultrasound imaging and shear wave elastography at baseline, 2-3 weeks after initiation of chemotherapy, and before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women with histologically confirmed breast cancer (by core needle biopsy)
- Women with >= 2 cm clinically or radiologically measureable breast cancer
- Women scheduled to receive neoadjuvant chemotherapy as part of their treatment plan
- Women competent to sign study specific written Informed Consent
- Women willing to comply with protocol requirements
Key exclusion criteria (5 listed)
- Women who are pregnant
- Women who have undergone open surgical (excisional) biopsy for breast cancer diagnosis
- Women who have had a prior history of breast cancer in the same breast
- Women with known cardiac shunt, pulmonary hypertension or hypersensitivity to perflutren agent
- Women 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 |
|---|---|---|
| dynamic contrast-enhanced ultrasound imagingAlso: DCE-USIUndergo CEUS | Procedure or surgery | Diagnostic (CEUS, SWE) |
| shear wave elastographyAlso: SWEUndergo SWE | Procedure or surgery | Diagnostic (CEUS, SWE) |
| Definity, (Lipid Microspheres) Intravenous SuspensionAlso: Perflutren Lipid MicrosphereParticipant will receive contrast agent by intravenous administration | Drug | Diagnostic (CEUS, SWE) |
| Philips Shear Wave ElastographyAlso: Shear Wave ElastographyEquipment used for SWE | Device | Diagnostic (CEUS, SWE) |
Primary outcome
Model predicted treatment response for CEUS and SWE
Time frame: Up to 1 year
Weighted Kappa will be used to assess the agreement.
Pathologically determined treatment response for CEUS and SWE
Time frame: Up to 1 year
Weighted Kappa will be used to assess the agreement.
2 secondary outcomes
Treatment response predicted by novel ultrasound techniques
Time frame: Up to 1 year
Treatment response predicted by CE MRI
Time frame: Up to 1 year
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
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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.
Linda Hovanessian-Larsen 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 Phase 1 study testing dynamic contrast-enhanced ultrasound imaging, shear wave elastography and Definity, (Lipid Microspheres) Intravenous Suspension in people with Breast Cancer, 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 25 Jan 2019. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Slow accrual). Results are not available in the source record.
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?
Model predicted treatment response for CEUS and SWE (time frame: Up to 1 year). The study lists 2 primary outcomes in all. 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 25 Jan 2019.