Proliferative Breast DiseaseEarly Phase 1NCT03954015
Comparison of Three Methods for Early Detection of Breast Cancer
A Early Phase 1 study testing Contrast Enhanced imaging and Lumason in people with Proliferative Breast Disease, run by Mayo Clinic at 1 site in United States.
Trial summary
Subjects with suspicious breast lesion (BIRADS category 4/5) who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with Contrast Enhanced Dual Energy Mammography (CEDM), Contrast Enhanced Breast MR (CEMR) and Contrast Enhanced Ultrasound (CEUS). Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Proliferative Breast Disease
- What is being tested?
- Contrast Enhanced imaging and Lumason
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2019to 5 Oct 2021
- 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 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Patients, greater than 30 years of age
- In good general health as evidenced by medical history
- BIRADS 4 or 5 suspicious breast lesions who are scheduled for breast biopsy.
Who cannot join
- Patients who are less than 30 years of age
- Have known or suspected cardiac shunts
- Have history of hypersensitive allergic reactions to any imaging contrast agents
- Pregnant (a urine pregnancy test will be given at no cost to the patient)
- Are nursing babies
- Poor renal function
- Are unwilling or unable (such as having a pacemaker) to undergo a CEMR
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contrast Enhanced Ultrasound (CEUS) With US Microvessel Imaging, Contrast Enhanced Dual Energy Mammography (CEDM) and Contrast Enhanced Breast MR (CEMR): Comparison of Three Methods for Early Detection of Breast Cancer
Subjects with suspicious breast lesion (BIRADS category 4/5) who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with Contrast Enhanced Dual Energy Mammography (CEDM), Contrast Enhanced Breast MR (CEMR) and Contrast Enhanced Ultrasound (CEUS).
Read the detailed description
The co-primary endpoints are to estimate the sensitivity and specificity of CEUS relative to pathology determined diagnosis.
- Positive predictive value of CEDM in detecting lesions seen on MR
- Estimate the negative predictive value (TN/(TN+FN)) of CEUS as an adjunct.
- Compare the frequency of recommendation of biopsy of MG±US vs MG±US plus CEUS as an adjunct based on BIRADS scores.
- Comparison of background enhancement seen on CEUS with that seen on CEDM and CEMR.
- Conditions
- Proliferative Breast Disease
- Being tested
- Contrast Enhanced imaging, Lumason
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast Enhanced imagingDiagnostic test
Also called Lumason
Contrast Enhanced Ultrasound (CEUS) with US Microvessel Imaging, Contrast Enhanced Dual Energy Mammography (CEDM) and Contrast Enhanced Breast MR (CEMR): Comparison of Three Methods for Early Detection of Breast Cancer.
LumasonDrug
FDA approved and used routinely for ultrasound exams of the heart and liver as well as the urinary tract in children. It contains microbubbles that are small enough to pass through the blood stream.
| Study group | Role | What they receive |
|---|---|---|
| patients over age 30 with suspicious BIRADS 4/5 Lesions | Other | Patients who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with CEDM, CEMR and CEUS. Receives: Diagnostic Test: Contrast Enhanced imaging; Drug: Lumason |
What is being measured
The primary outcome is the main question the study is designed to answer.
CEUS true positive diagnosis
The number of CEUS true positive diagnosis defined as suspicious enhancement/ mass corresponding to area of malignant pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram.
Measured: 1 year
CEUS false positive diagnosis
The number of CEUS false positive diagnosis defined as suspicious enhancement corresponding to area of benign pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram
Measured: 1 year
CEUS true negative diagnosis
The number of CEUS true negative diagnosis defined as no enhancement corresponding to area of malignant pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram.
Measured: 1 year
CEUS false negative diagnosis
The number of CEUS false negative diagnosis defined as no enhancement corresponding to area of benign pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start15 Oct 2019
- Primary completion30 Jun 2020
- Study completion5 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Breast DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katrina N. Glazebrook, M.B., Ch.B., Mayo Clinic
- Investigators
- Katrina N. Glazebrook, M.B., Ch.B., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954015
- Sponsor's protocol ID
- 18-003544
- Status last verified
- Jan 2022
- First submitted
- 5 Mar 2019
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast Enhanced Ultrasound (CEUS) With US Microvessel Imaging, Contrast Enhanced Dual Energy Mammography (CEDM) and Contrast Enhanced Breast MR (CEMR): Comparison of Three Methods for Early Detection of Breast Cancer
- ClinicalTrials.gov ID
- NCT03954015
- Acronym / sponsor ID
- 18-003544
- Conditions
- Proliferative Breast Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 5 Oct 2021 (actual)
- First posted
- 17 May 2019 (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.
Subjects with suspicious breast lesion (BIRADS category 4/5) who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with Contrast Enhanced Dual Energy Mammography (CEDM), Contrast Enhanced Breast MR (CEMR) and Contrast Enhanced Ultrasound (CEUS).
Detailed description
The co-primary endpoints are to estimate the sensitivity and specificity of CEUS relative to pathology determined diagnosis.
- Positive predictive value of CEDM in detecting lesions seen on MR
- Estimate the negative predictive value (TN/(TN+FN)) of CEUS as an adjunct.
- Compare the frequency of recommendation of biopsy of MG±US vs MG±US plus CEUS as an adjunct based on BIRADS scores.
- Comparison of background enhancement seen on CEUS with that seen on CEDM and CEMR.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients over age 30 with suspicious BIRADS 4/5 Lesions | Other | Diagnostic Test: Contrast Enhanced imaging, Drug: LumasonPatients who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with CEDM, CEMR and CEUS. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Patients, greater than 30 years of age
- In good general health as evidenced by medical history
- BIRADS 4 or 5 suspicious breast lesions who are scheduled for breast biopsy.
Key exclusion criteria (7 listed)
- Patients who are less than 30 years of age
- Have known or suspected cardiac shunts
- Have history of hypersensitive allergic reactions to any imaging contrast agents
- Pregnant (a urine pregnancy test will be given at no cost to the patient)
- Are nursing babies
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 Enhanced imagingAlso: LumasonContrast Enhanced Ultrasound (CEUS) with US Microvessel Imaging, Contrast Enhanced Dual Energy Mammography (CEDM) and Contrast Enhanced Breast MR (CEMR): Comparison of Three Methods for Early Detection of Breast Cancer. | Diagnostic test | patients over age 30 with suspicious BIRADS 4/5 Lesions |
| LumasonFDA approved and used routinely for ultrasound exams of the heart and liver as well as the urinary tract in children. It contains microbubbles that are small enough to pass through the blood stream. | Drug | patients over age 30 with suspicious BIRADS 4/5 Lesions |
Primary outcome
CEUS true positive diagnosis
Time frame: 1 year
The number of CEUS true positive diagnosis defined as suspicious enhancement/ mass corresponding to area of malignant pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram.
CEUS false positive diagnosis
Time frame: 1 year
The number of CEUS false positive diagnosis defined as suspicious enhancement corresponding to area of benign pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram
CEUS true negative diagnosis
Time frame: 1 year
The number of CEUS true negative diagnosis defined as no enhancement corresponding to area of malignant pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram.
CEUS false negative diagnosis
Time frame: 1 year
The number of CEUS false negative diagnosis defined as no enhancement corresponding to area of benign pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Mayo Clinic 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. This study is not recruiting at the moment.
Katrina N. Glazebrook, M.B., Ch.B. principal investigator
Mayo Clinic
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 Contrast Enhanced imaging and Lumason in people with Proliferative Breast Disease, run by Mayo Clinic 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 7 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 10 Jan 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CEUS true positive diagnosis (time frame: 1 year). The study lists 4 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 Jan 2022.