Breast CancerNCT02115607

Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy

A study testing Definity infusion in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: Definity infusion
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: Mar 2014to 23 May 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Females
Be diagnosed with T1 or greater LABC, any N and M0.
Be scheduled for neoadjuvant chemotherapy
Be at least 21 years of age.
Be medically stable.
If a female of child-bearing potential, must have a negative pregnancy test.
Have signed Informed Consent to participate in the study.

Who cannot join

Males
Females who are pregnant or nursing.
Patients with other primary cancers requiring systemic treatment.
Patients with any metastatic disease.
Patients undergoing neoadjuvant endocrine therapy.
Patients with known hypersensitivity or allergy to any component of Definity.

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Patients with cardiac shunts or congenital heart defects.
Patients with unstable cardiopulmonary conditions or respiratory distress syndrome.
Patients with uncontrollable emphysema, pulmonary vasculitis, pulmonary hypertension or a history of pulmonary emboli.
Patients who have received any contrast medium (X-ray, MRI, CT or US) in the 24 hours prior to the research US exam.

Trial locations and contacts

1 site in 1 country.

United States1 site

Thomas Jefferson University
Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: Quantitative Subharmonic Breast Imaging: Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy

This is a diagnostic accuracy study to evaluate if two novel ultrasound (US) techniques, quantitative 3D subharmonic imaging (SHI) and Subharmonic Aided Pressure Estimation (SHAPE), used with an intravenous ultrasound contrast agent (Definity, Lantheus Medical Imaging, Billerica, MA), can track changes in locally advanced breast cancer (LABC) angiogenesis and interstitial fluid pressure (IFP), respectively, by studying women undergoing neoadjuvant chemotherapy before as well as with around 10% and 60% (in part 1) or 30% (in part 2) of the neoadjuvant chemotherapy treatment delivered and after completion of the neoadjuvant chemotherapy treatment. Results will be compared to MRI and pathology.

Conditions: Breast Cancer
Being tested: Definity infusion
Keywords: Breast cancer, Interstitial fluid pressure, Angiogenesis, Contrast enhanced ultrasound imaging, Subharmonic imaging, Subharmonic pressure estimation
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Definity infusionDrug
Also called Perflutren Lipid Microspheres
3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min

Study groups in NCT02115607
Study group	Role	What they receive
Definity infusion	Experimental	Infusion of Definity (Perflutren Lipid Microspheres) Receives: Drug: Definity infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

Subharmonic Aided Pressure Estimation (SHAPE) After Treatment for Complete Responders
To evaluate the ability of SHAPE, used with Definity, to track changes in interstitial fluid pressure (IFP) by studying women undergoing neoadjuvant chemotherapy before as well as with around 10% and 30% of the neoadjuvant chemotherapy treatment delivered and comparing results to MRI and pathology.
Measured: from baseline to completion of neoadjuvant chemotherapy, average of 6 months
Subharmonic Aided Pressure Estimation (SHAPE) After Treatment for Partial Responders
To evaluate the ability of SHAPE, used with Definity, to track changes in interstititial fluid (IFP) by studying women undergoing neoadjuvant chemotherapy before as well as with around 10% 30% of the neoadjuvant chemotherapy treatment delivered and after completion of the neoadjuvant chemotherapy treatment and comparing results to MRI and pathology.
Measured: from baseline to completion of neoadjuvant chemotherapy

Secondary outcomes (2)

Subharmonic Imaging (SHI) Depiction of Breast Cancer Angiogenesis for Complete Responders
To compare the 3D Subharmonic imaging (SHI) depiction of breast cancer angiogenesis in humans to CD31, an immunohistochemical predictor of angiogenesis.
Measured: From baseline to after surgery
SHI Depiction of Breast Cancer Angiogenesis for Partial Responders
To compare the 3D SHI depiction of breast cancer angiogenesis in humans to CD31, an immunohistochemical predictor of angiogenesis.
Measured: After surgery; on average 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 201423 May 2018

First posted16 Apr 2014 (estimated)
Study startMar 2014
Primary completion23 May 2018
Study completion23 May 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
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 N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02115607
Sponsor's protocol ID: 13S.215
Other IDs: JT 2973
Status last verified: May 2025
First submitted: 24 Mar 2014
Last updated: 6 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Quantitative Subharmonic Breast Imaging: Subharmonic Imaging and Pressure Estimation for Monitoring Neoadjuvant Chemotherapy
ClinicalTrials.gov ID: NCT02115607
Acronym / sponsor ID: 13S.215
Conditions: Breast Cancer
Keywords: Breast cancer, Interstitial fluid pressure, Angiogenesis, Contrast enhanced ultrasound imaging, Subharmonic imaging, Subharmonic pressure estimation
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
Collaborators: U.S. Army Medical Research and Development Command
Study start: Mar 2014
Primary completion: 23 May 2018 (actual)
Study completion: 23 May 2018 (actual)
First posted: 16 Apr 2014 (estimated)
Results: Posted 31 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Definity infusion	Experimental	Drug: Definity infusionInfusion of Definity (Perflutren Lipid Microspheres)

Who may qualify

Ages: 21 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Females
Be diagnosed with T1 or greater LABC, any N and M0.
Be scheduled for neoadjuvant chemotherapy
Be at least 21 years of age.
Be medically stable.

Key exclusion criteria (10 listed)

Males
Females who are pregnant or nursing.
Patients with other primary cancers requiring systemic treatment.
Patients with any metastatic disease.
Patients undergoing neoadjuvant endocrine therapy.

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
Definity infusionAlso: Perflutren Lipid Microspheres3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min	Drug	Definity infusion

Primary outcome

Subharmonic Aided Pressure Estimation (SHAPE) After Treatment for Complete Responders
Time frame: from baseline to completion of neoadjuvant chemotherapy, average of 6 months
To evaluate the ability of SHAPE, used with Definity, to track changes in interstitial fluid pressure (IFP) by studying women undergoing neoadjuvant chemotherapy before as well as with around 10% and 30% of the neoadjuvant chemotherapy treatment delivered and comparing results to MRI and pathology.
Subharmonic Aided Pressure Estimation (SHAPE) After Treatment for Partial Responders
Time frame: from baseline to completion of neoadjuvant chemotherapy
To evaluate the ability of SHAPE, used with Definity, to track changes in interstititial fluid (IFP) by studying women undergoing neoadjuvant chemotherapy before as well as with around 10% 30% of the neoadjuvant chemotherapy treatment delivered and after completion of the neoadjuvant chemotherapy treatment and comparing results to MRI and pathology.

2 secondary outcomes

Subharmonic Imaging (SHI) Depiction of Breast Cancer Angiogenesis for Complete Responders
Time frame: From baseline to after surgery
SHI Depiction of Breast Cancer Angiogenesis for Partial Responders
Time frame: After surgery; on average 6 months

Results and safety

Results posted to the registry on 31 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Definity Infusion	17	16

Primary outcome: Subharmonic Aided Pressure Estimation (SHAPE) After Treatment for Complete Responders

Time frame: from baseline to completion of neoadjuvant chemotherapy, average of 6 months. Mean (Standard Deviation). Unit: dB

Measure	Definity Infusion n = 6
10% completion of neoadjuvant chemotherapy for	3.23 (1.41)
30% completion of neoadjuvant chemotherapy	1.67 (1.09)

Population analysed: six participants were not counted in the data analysis. 2 due to technical issues, 2 withdrew due to worsening of underlying disease, and 2 stopped their nedoadjuvant chemotherapy treatment unexpectedly. Data presented below is for those who achieved Complete Response (CR)

Primary outcome: Subharmonic Aided Pressure Estimation (SHAPE) After Treatment for Partial Responders

Time frame: from baseline to completion of neoadjuvant chemotherapy. Mean (Standard Deviation). Unit: dB

Measure	Definity Infusion n = 5
10% completion of neoadjuvant chemotherapy for	-0.88 (1.46)
30% completion of neoadjuvant chemotherapy	0.06 (0.90)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 1 hour post infusion of contrast agent. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Definity Infusion	0 of 17 (0%)	0 of 17 (0%)	3 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Thomas Jefferson University HospitalLink provided by the sponsor.

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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.

Flemming Forsberg, PhD principal investigator

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 study testing Definity infusion in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at 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 7 inclusion and 10 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 6 May 2025. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Subharmonic Aided Pressure Estimation (SHAPE) After Treatment for Complete Responders (time frame: from baseline to completion of neoadjuvant chemotherapy, average of 6 months). 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?

On the ClinicalTrials.gov record for NCT02115607.

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 6 May 2025.