Breast CancerEarly Phase 1NCT05957042
Pilot Study to Evaluate if Contrast Enhanced Ultrasound (CEUS) Can Predict Treatment Response in Triple Negative Breast Cancer (TNBC) Patients Receiving Combined Chemotherapy and Immune Checkpoint Inhibitors (ICI).
A Early Phase 1 study testing Lumason in people with Breast Cancer and Contrast Enhanced Ultrasound, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
To find out if contrast enhanced ultrasound (CEUS) can be used to determine if patients receiving combined ICI therapy for triple negative breast cancer (TNBC) are responding to treatment earlier than standard of care MR or CT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Contrast Enhanced Ultrasound
- What is being tested?
- Lumason
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 1 Sep 2031
- 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
- Willingness and ability to sign and date the study-specific informed consent form.
- Stated willingness to comply with all study procedures and attend all study visits to the best of his or her ability for the duration of the study.
- Age greater than 18yo.
- Stage I-III TNBC or stage IV TNBC with intact breast primary.
- Planned combined ICI therapy as per SoC by treating oncologist.
Who cannot join
- Other clinical trials are not excluded but participation must be cleared with the other clinical trial PIs.
- Patients not suitable to undergo contrast enhanced ultrasound (i.e., pregnant women, known allergy to eggs, or a past allergic reaction to sonographic contrast or its components, such as polyethylene glycol (PEG))
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Health College of Medicine
Hershey, Pennsylvania, 17033
About this study
To find out if contrast enhanced ultrasound (CEUS) can be used to determine if patients receiving combined ICI therapy for triple negative breast cancer (TNBC) are responding to treatment earlier than standard of care MR or CT.
- Conditions
- Breast Cancer, Contrast Enhanced Ultrasound
- Being tested
- Lumason
- Keywords
- Breast Cancer, Contrast Enhanced Ultrasound
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumasonDrug
Up to 4.8mL administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| Contrast Enhanced Ultrasound (with Lumason) | Experimental | Not described Receives: Drug: Lumason |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at Baseline
Measured: Day 0 (Baseline)
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C2
Measured: No later than week 5
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C3
Measured: No later than week 9
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C4
Measured: No later than week 13
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at Baseline
Measured: Day 0 (Baseline)
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C2
Measured: No later than week 5
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C3
Measured: No later than week 9
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C4
Measured: No later than week 13
Number of subjects who respond to treatment as reported on routine imaging.
Measured: No later than week 17
Secondary outcomes (8)
Change in area under the curve (CEUS metric) between Baseline & C2
Measured: No later than year 5
Change in area under the curve (CEUS metric) between Baseline & C3
Measured: No later than year 5
Change in area under the curve (CEUS metric) between Baseline & C4
Measured: No later than year 5
Change in area under the curve (CEUS metric) between C2 & C3
Measured: No later than year 5
Change in area under the curve (CEUS metric) between C2 & C4
Measured: No later than year 5
Change in area under the curve (CEUS metric) between C3 & C4
Measured: No later than year 5
Number of subjects having pathologic complete response
Measured: No later than year 5
Overall survival (time to subject death)
Measured: No later than year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start1 Sep 2023
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2031 (estimated)
Why it stopped: Responsible Party left the institution and the study will not be started by other investigator
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 Milton S. Hershey Medical CenterThe 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
- Model description
- Evaluate whether CEUS can predict response on gold standard imaging in the same individuals
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Patton, Milton S. Hershey Medical Center
- Investigators
- Seth Hardy, M.D., Principal investigator, Assistant Professor - Department of Radiology, Penn State Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957042
- Sponsor's protocol ID
- 22769
- Status last verified
- Dec 2025
- First submitted
- 12 Jul 2023
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate if Contrast Enhanced Ultrasound (CEUS) Can Predict Treatment Response in Triple Negative Breast Cancer (TNBC) Patients Receiving Combined Chemotherapy and Immune Checkpoint Inhibitors (ICI).
- ClinicalTrials.gov ID
- NCT05957042
- Acronym / sponsor ID
- 22769
- Conditions
- Breast Cancer, Contrast Enhanced Ultrasound
- Keywords
- Breast Cancer, Contrast Enhanced Ultrasound
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Responsible Party left the institution and the study will not be started by other investigator
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 24 Jul 2023 (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.
To find out if contrast enhanced ultrasound (CEUS) can be used to determine if patients receiving combined ICI therapy for triple negative breast cancer (TNBC) are responding to treatment earlier than standard of care MR or CT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Evaluate whether CEUS can predict response on gold standard imaging in the same individuals
| Arm | Type | Receives |
|---|---|---|
| Contrast Enhanced Ultrasound (with Lumason) | Experimental | Drug: Lumason |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willingness and ability to sign and date the study-specific informed consent form.
- Stated willingness to comply with all study procedures and attend all study visits to the best of his or her ability for the duration of the study.
- Age greater than 18yo.
- Stage I-III TNBC or stage IV TNBC with intact breast primary.
- Planned combined ICI therapy as per SoC by treating oncologist.
Key exclusion criteria (2 listed)
- Other clinical trials are not excluded but participation must be cleared with the other clinical trial PIs.
- Patients not suitable to undergo contrast enhanced ultrasound (i.e., pregnant women, known allergy to eggs, or a past allergic reaction to sonographic contrast or its components, such as polyethylene glycol (PEG))
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 |
|---|---|---|
| LumasonUp to 4.8mL administered intravenously | Drug | Contrast Enhanced Ultrasound (with Lumason) |
Primary outcome
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at Baseline
Time frame: Day 0 (Baseline)
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C2
Time frame: No later than week 5
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C3
Time frame: No later than week 9
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C4
Time frame: No later than week 13
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at Baseline
Time frame: Day 0 (Baseline)
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C2
Time frame: No later than week 5
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C3
Time frame: No later than week 9
Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C4
Time frame: No later than week 13
Number of subjects who respond to treatment as reported on routine imaging.
Time frame: No later than week 17
8 secondary outcomes
Change in area under the curve (CEUS metric) between Baseline & C2
Time frame: No later than year 5
Change in area under the curve (CEUS metric) between Baseline & C3
Time frame: No later than year 5
Change in area under the curve (CEUS metric) between Baseline & C4
Time frame: No later than year 5
Change in area under the curve (CEUS metric) between C2 & C3
Time frame: No later than year 5
Change in area under the curve (CEUS metric) between C2 & C4
Time frame: No later than year 5
Change in area under the curve (CEUS metric) between C3 & C4
Time frame: No later than year 5
Number of subjects having pathologic complete response
Time frame: No later than year 5
Overall survival (time to subject death)
Time frame: No later than year 5
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Seth Hardy, M.D. principal investigator
Assistant Professor - Department of Radiology, Penn State Health
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 Lumason in people with Breast Cancer and Contrast Enhanced Ultrasound, run by Milton S. Hershey Medical Center 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 2 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: withdrawn, as of the sponsor's last update on 10 Dec 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.
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 was withdrawn before enrolling participants, so there are no results.
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?
Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at Baseline (time frame: Day 0 (Baseline)). The study lists 9 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 10 Dec 2025.