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WithdrawnNCT05957042Updated Dec 10, 2025

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).

An Early Phase 1 interventional study of Lumason in Breast Cancer and Contrast Enhanced Ultrasound, sponsored by Milton S. Hershey Medical Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-10.

Sponsored by Milton S. Hershey Medical Center · Early Phase 1, Interventional, and Diagnostic

Why this study was withdrawn
Responsible Party left the institution and the study will not be started by other investigator
Phase
Early Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Breast Cancer
  • Contrast Enhanced Ultrasound

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Keywords

  • Breast Cancer
  • Contrast Enhanced Ultrasound
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

Browse Breast Neoplasms studies →

Lead sponsor

Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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))
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Study design

Phase
Early Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Contrast Enhanced Ultrasound (with Lumason)

    Drug: Lumason

Interventions

  • DrugLumason

    Up to 4.8mL administered intravenously

06

What researchers measure

Primary outcomes

  1. Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at Baseline

    Time frame: Day 0 (Baseline)

  2. Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C2

    Time frame: No later than week 5

  3. Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C3

    Time frame: No later than week 9

  4. Volume of mass on as visualized on contrast (Lumason) enhanced ultrasound at C4

    Time frame: No later than week 13

  5. Contrast (Lumason) enhanced ultrasound metric-area under the curve-at Baseline

    Time frame: Day 0 (Baseline)

  6. Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C2

    Time frame: No later than week 5

  7. Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C3

    Time frame: No later than week 9

  8. Contrast (Lumason) enhanced ultrasound metric-area under the curve-at C4

    Time frame: No later than week 13

  9. Number of subjects who respond to treatment as reported on routine imaging.

    Time frame: No later than week 17

Secondary outcomes

  1. Change in area under the curve (CEUS metric) between Baseline & C2

    Time frame: No later than year 5

  2. Change in area under the curve (CEUS metric) between Baseline & C3

    Time frame: No later than year 5

  3. Change in area under the curve (CEUS metric) between Baseline & C4

    Time frame: No later than year 5

  4. Change in area under the curve (CEUS metric) between C2 & C3

    Time frame: No later than year 5

  5. Change in area under the curve (CEUS metric) between C2 & C4

    Time frame: No later than year 5

  6. Change in area under the curve (CEUS metric) between C3 & C4

    Time frame: No later than year 5

  7. Number of subjects having pathologic complete response

    Time frame: No later than year 5

  8. Overall survival (time to subject death)

    Time frame: No later than year 5

07

Study locations

1 site
  • Penn State Health College of Medicine
    Hershey, Pennsylvania 17033, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05957042
Lead sponsor
Milton S. Hershey Medical Center
Responsible party
Stephanie Patton (Compliance Specialist-RQA, Milton S. Hershey Medical Center) — Principal investigator
First posted
Jul 24, 2023
Start date
Sep 1, 2023
Primary completion
Sep 1, 2026 (estimated)
Completion
Sep 1, 2031 (estimated)
Last update
Dec 10, 2025

Study contacts

Seth Hardy, M.D.
principal investigator · Assistant Professor - Department of Radiology, Penn State Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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