Breast CancerPhase 2NCT07225114
Translation of Acoustic Angiography: Contrast Enhanced Super Resolution (CESR) Imaging
A Phase 2 study testing contrast agent perflutren lipid and Ultrasound Imaging in people with Breast Cancer and Kidney Neoplasms, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This is a 4-arm, single-center study involving 40 participants. Ten healthy volunteers will be enrolled for system imaging optimization, and thirty (30) patients with previously identified lesions in the breast, liver, or kidney-based on prior ultrasound or cross-sectional imaging-will be imaged. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Kidney Neoplasms, Liver Neoplasms
- What is being tested?
- contrast agent perflutren lipid and Ultrasound Imaging
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2025to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥18 years old
- Patient had a diagnostic ultrasound study performed at University of North Carolina
- Scheduled for a biopsy
- Lesion visualized on ultrasound
- Able to provide informed consent
- Negative urine pregnancy test in women of child-bearing potential
Who cannot join
- Institutionalized subject (prisoner or nursing home patient)
- Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease (COPD)
- Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®)
- Active cardiac disease including any of the following
- Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association)
- Unstable angina.
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- Severe arrhythmia (i.e., ventricular tachycardia, flutter fibrillation; ventricular premature complexes occurring close to the preceding T-wave, multifocal complexes).
- Myocardial infarction within 14 days prior to the date of proposed Definity® administration.
- Pulmonary hypertension
- Cardiac shunts
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of North Carolina
Chapel Hill, North Carolina, 27599
Markeela Lipscomb, 919-984-0000, markeela_lipscomb@med.unc.edu
Desma Jones, (919) - 966-3036, desma_jones@med.unc.edu
About this study
Official title: Academic-Industrial Partnership for Translation of Acoustic Angiography: Contrast Enhanced Super Resolution (CESR) Imaging
This is a 4-arm, single-center study involving 40 participants. Ten healthy volunteers will be enrolled for system imaging optimization, and thirty (30) patients with previously identified lesions in the breast, liver, or kidney-based on prior ultrasound or cross-sectional imaging-will be imaged. Recruitment will be conducted such that ten patients are included from each anatomic region.
The fourth arm will consist of 10 healthy volunteers who will be imaged to allow optimization of imaging parameters. Optimization is is required again due to the use of a different ultrasound system employing a new imaging technique. Parameters such as frame rate, power, depth of imaging, and linear translation rate will be adjusted during this process.
The primary objectives of the study are to assess the sensitivity and specificity of Contrast Enhanced Super-Resolution (CESR) imaging in evaluating known lesions in the breast, liver, and kidney. These results will be compared with pathological findings. The secondary objectives are to compare the sensitivity and specificity of CESR imaging with those of traditional B-mode ultrasound in differentiating malignant from benign lesions in these same organs.
- Conditions
- Breast Cancer, Kidney Neoplasms, Liver Neoplasms
- Being tested
- contrast agent perflutren lipid, Ultrasound Imaging
- Keywords
- Definity®, perflutren lipid, healthy volunteers, ultrasound, cross-sectional imaging
- Medical subject headings
- Breast Neoplasms, Kidney Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast agent perflutren lipidDrug
At the time of imaging, the contrast agent perflutren lipid will be administered, intravenous (IV). All patients will be visually monitored for signs or symptoms of a contrast administration reaction once the drug is administered for a 15-minute period.
Ultrasound ImagingDevice
Also called Contrast Enhanced Super Resolution (CESR)
Contrast Enhanced Super Resolution (CESR) imaging involves a research ultrasound scanner as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to CESR imaging for localization.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Healthy Volunteers | Experimental | Participants without any disease diagnosis. Receives: Drug: contrast agent perflutren lipid; Device: Ultrasound Imaging |
| Arm 2: Breast Imaging Patients | Experimental | Participants are going to be assessed breast cancer. Receives: Drug: contrast agent perflutren lipid; Device: Ultrasound Imaging |
| Arm 3: Kidney Imaging Patients | Experimental | Participants are going to be assessed kidney cancer. Receives: Drug: contrast agent perflutren lipid; Device: Ultrasound Imaging |
| Arm 4: Liver Imaging Patients | Experimental | Participants are going to be assessed liver cancer. Receives: Drug: contrast agent perflutren lipid; Device: Ultrasound Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of Contrast Enhanced Super-Resolution (CESR) breast imaging
Sensitivity of Contrast Enhanced Super-Resolution (CESR) breast imaging will be evaluated by comparing image analyses to the pathological results for these lesions.
Sensitivity will be defined as the proportion of lesions detected by CESR to be positive among lesions confirmed as positive by pathological results.
Measured: Biopsy date (Up to 2 months)
Specificity of Contrast Enhanced Super-Resolution (CESR) breast imaging
Specificity of Contrast Enhanced Super-Resolution (CESR) breast imaging will be evaluated by comparing image analyses to the pathological results for these lesions.
Specificity will be defined as the proportion of lesions detected by CESR to be negative among lesions confirmed as negative by pathological results.
Measured: Biopsy date (Up to 2 months)
Sensitivity of Contrast Enhanced Super-Resolution (CESR) kidney imaging
Sensitivity of Contrast Enhanced Super-Resolution (CESR) kidney imaging will be evaluated by comparing image analyses to the pathological results for these lesions.
Sensitivity will be defined as the proportion of lesions detected by CESR to be positive among lesions confirmed as positive by pathological results.
Measured: Biopsy date (Up to 2 months)
Specificity of Contrast Enhanced Super-Resolution (CESR) kidney imaging
Specificity of Contrast Enhanced Super-Resolution (CESR) kidney imaging will be evaluated by comparing image analyses to the pathological results for these lesions.
Specificity will be defined as the proportion of lesions detected by CESR to be negative among lesions confirmed as negative by pathological results.
Measured: Biopsy date (Up to 2 months)
Sensitivity of Contrast Enhanced Super-Resolution (CESR) liver imaging
Sensitivity of Contrast Enhanced Super-Resolution (CESR) liver imaging will be evaluated by comparing image analyses to the pathological results for these lesions.
Sensitivity will be defined as the proportion of lesions detected by CESR to be positive among lesions confirmed as positive by pathological results.
Measured: Biopsy date (Up to 2 months)
Specificity of Contrast Enhanced Super-Resolution (CESR) liver imaging
Specificity of Contrast Enhanced Super-Resolution (CESR) liver imaging will be evaluated by comparing image analyses to the pathological results for these lesions.
Specificity will be defined as the proportion of lesions detected by CESR to be negative among lesions confirmed as negative by pathological results.
Measured: Biopsy date (Up to 2 months)
Secondary outcomes (3)
Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- breast
The sensitivity and specificity of CESR imaging with traditional b-mode ultrasound will be compared in the distinction of malignant versus benign breast lesions.
Measured: Biopsy date (Up to 2 months)
Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- kidney
The sensitivity and specificity of CESR imaging with traditional b-mode ultrasound will be compared in the distinction of malignant versus benign kidney lesions.
Measured: Biopsy date (Up to 2 months)
Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- liver
The sensitivity and specificity of CESR imaging with traditional b-mode ultrasound will be compared in the distinction of malignant versus benign liver lesions.
Measured: Biopsy date (Up to 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2025
- Study start4 Nov 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
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 UNC Lineberger Comprehensive Cancer 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
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Yueh Lee, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225114
- Sponsor's protocol ID
- LCCC2451
- Other IDs
- R01CA220681
- Status last verified
- Jun 2026
- First submitted
- 3 Nov 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Academic-Industrial Partnership for Translation of Acoustic Angiography: Contrast Enhanced Super Resolution (CESR) Imaging
- ClinicalTrials.gov ID
- NCT07225114
- Acronym / sponsor ID
- LCCC2451
- Conditions
- Breast Cancer, Kidney Neoplasms, Liver Neoplasms
- Keywords
- Definity®, perflutren lipid, healthy volunteers, ultrasound, cross-sectional imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Nov 2025 (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.
This is a 4-arm, single-center study involving 40 participants. Ten healthy volunteers will be enrolled for system imaging optimization, and thirty (30) patients with previously identified lesions in the breast, liver, or kidney-based on prior ultrasound or cross-sectional imaging-will be imaged. Recruitment will be conducted such that ten patients are included from each anatomic region.
The fourth arm will consist of 10 healthy volunteers who will be imaged to allow optimization of imaging parameters. Optimization is is required again due to the use of a different ultrasound system employing a new imaging technique. Parameters such as frame rate, power, depth of imaging, and linear translation rate will be adjusted during this process.
The primary objectives of the study are to assess the sensitivity and specificity of Contrast Enhanced Super-Resolution (CESR) imaging in evaluating known lesions in the breast, liver, and kidney. These results will be compared with pathological findings. The secondary objectives are to compare the sensitivity and specificity of CESR imaging with those of traditional B-mode ultrasound in differentiating malignant from benign lesions in these same organs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Healthy Volunteers | Experimental | Drug: contrast agent perflutren lipid, Device: Ultrasound ImagingParticipants without any disease diagnosis. |
| Arm 2: Breast Imaging Patients | Experimental | Drug: contrast agent perflutren lipid, Device: Ultrasound ImagingParticipants are going to be assessed breast cancer. |
| Arm 3: Kidney Imaging Patients | Experimental | Drug: contrast agent perflutren lipid, Device: Ultrasound ImagingParticipants are going to be assessed kidney cancer. |
| Arm 4: Liver Imaging Patients | Experimental | Drug: contrast agent perflutren lipid, Device: Ultrasound ImagingParticipants are going to be assessed liver cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults ≥18 years old
- Patient had a diagnostic ultrasound study performed at University of North Carolina
- Scheduled for a biopsy
- Lesion visualized on ultrasound
- Able to provide informed consent
Key exclusion criteria (10 listed)
- Institutionalized subject (prisoner or nursing home patient)
- Critically ill or medically unstable and whose critical course during the observation period would be unpredictable (e.g., chronic obstructive pulmonary disease (COPD)
- Known hypersensitivity to sulfur hexafluoride or to any component of perflutren lipid (Definity®)
- Active cardiac disease including any of the following
- Severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association)
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 |
|---|---|---|
| contrast agent perflutren lipidAt the time of imaging, the contrast agent perflutren lipid will be administered, intravenous (IV). All patients will be visually monitored for signs or symptoms of a contrast administration reaction once the drug is administered for a 15-minute period. | Drug | Arm 1: Healthy Volunteers, Arm 2: Breast Imaging Patients, Arm 3: Kidney Imaging Patients, Arm 4: Liver Imaging Patients |
| Ultrasound ImagingAlso: Contrast Enhanced Super Resolution (CESR)Contrast Enhanced Super Resolution (CESR) imaging involves a research ultrasound scanner as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to CESR imaging for localization. | Device | Arm 1: Healthy Volunteers, Arm 2: Breast Imaging Patients, Arm 3: Kidney Imaging Patients, Arm 4: Liver Imaging Patients |
Primary outcome
Sensitivity of Contrast Enhanced Super-Resolution (CESR) breast imaging
Time frame: Biopsy date (Up to 2 months)
Sensitivity of Contrast Enhanced Super-Resolution (CESR) breast imaging will be evaluated by comparing image analyses to the pathological results for these lesions. Sensitivity will be defined as the proportion of lesions detected by CESR to be positive among lesions confirmed as positive by pathological results.
Specificity of Contrast Enhanced Super-Resolution (CESR) breast imaging
Time frame: Biopsy date (Up to 2 months)
Specificity of Contrast Enhanced Super-Resolution (CESR) breast imaging will be evaluated by comparing image analyses to the pathological results for these lesions. Specificity will be defined as the proportion of lesions detected by CESR to be negative among lesions confirmed as negative by pathological results.
Sensitivity of Contrast Enhanced Super-Resolution (CESR) kidney imaging
Time frame: Biopsy date (Up to 2 months)
Sensitivity of Contrast Enhanced Super-Resolution (CESR) kidney imaging will be evaluated by comparing image analyses to the pathological results for these lesions. Sensitivity will be defined as the proportion of lesions detected by CESR to be positive among lesions confirmed as positive by pathological results.
Specificity of Contrast Enhanced Super-Resolution (CESR) kidney imaging
Time frame: Biopsy date (Up to 2 months)
Specificity of Contrast Enhanced Super-Resolution (CESR) kidney imaging will be evaluated by comparing image analyses to the pathological results for these lesions. Specificity will be defined as the proportion of lesions detected by CESR to be negative among lesions confirmed as negative by pathological results.
Sensitivity of Contrast Enhanced Super-Resolution (CESR) liver imaging
Time frame: Biopsy date (Up to 2 months)
Sensitivity of Contrast Enhanced Super-Resolution (CESR) liver imaging will be evaluated by comparing image analyses to the pathological results for these lesions. Sensitivity will be defined as the proportion of lesions detected by CESR to be positive among lesions confirmed as positive by pathological results.
Specificity of Contrast Enhanced Super-Resolution (CESR) liver imaging
Time frame: Biopsy date (Up to 2 months)
Specificity of Contrast Enhanced Super-Resolution (CESR) liver imaging will be evaluated by comparing image analyses to the pathological results for these lesions. Specificity will be defined as the proportion of lesions detected by CESR to be negative among lesions confirmed as negative by pathological results.
3 secondary outcomes
Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- breast
Time frame: Biopsy date (Up to 2 months)
Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- kidney
Time frame: Biopsy date (Up to 2 months)
Comparison of Contrast Enhanced Super-Resolution (CESR) imaging with traditional b-mode ultrasound- liver
Time frame: Biopsy date (Up to 2 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- 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.
Yueh Lee, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing contrast agent perflutren lipid and Ultrasound Imaging in people with Breast Cancer and Kidney Neoplasms, run by UNC Lineberger Comprehensive Cancer 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 6 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: looking for participants now, as of the sponsor's last update on 8 Jun 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Desma Jones ((919) 843-9463, desma_jones@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Contrast Enhanced Super-Resolution (CESR) breast imaging (time frame: Biopsy date (Up to 2 months)). The study lists 6 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 8 Jun 2026.