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出境医 / 临床实验 / Comparison of Three Methods for Early Detection of Breast Cancer
Comparison of Three Methods for Early Detection of Breast Cancer
Study Description
Brief 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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Proliferative Breast Disease | Diagnostic Test: Contrast Enhanced imaging Drug: Lumason | Early Phase 1 |
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
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| 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 |
| Actual Study Start Date : | October 15, 2019 |
| Estimated Primary Completion Date : | June 2021 |
| Estimated Study Completion Date : | June 2021 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
patients over age 30 with suspicious BIRADS 4/5 Lesions
Patients who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with CEDM, CEMR and CEUS.
|
Diagnostic Test: Contrast Enhanced imaging
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.
Other Name: Lumason
Drug: Lumason 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.
|
Outcome Measures
Primary Outcome Measures :
- 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.
Eligibility Criteria
| Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | females greater than 30 years of age |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Contacts and Locations
Locations
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
Sponsors and Collaborators
Mayo Clinic
Investigators
| Principal Investigator: | Katrina N. Glazebrook, M.B., Ch.B. | Mayo Clinic |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | March 5, 2019 | ||||||
| First Posted Date ICMJE | May 17, 2019 | ||||||
| Last Update Posted Date | November 6, 2020 | ||||||
| Actual Study Start Date ICMJE | October 15, 2019 | ||||||
| Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Comparison of Three Methods for Early Detection of Breast Cancer | ||||||
| Official Title ICMJE | 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 | ||||||
| Brief 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). | ||||||
| Detailed Description |
The co-primary endpoints are to estimate the sensitivity and specificity of CEUS relative to pathology determined diagnosis.
|
||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Early Phase 1 | ||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
||||||
| Condition ICMJE | Proliferative Breast Disease | ||||||
| Intervention ICMJE |
|
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| Study Arms ICMJE | patients over age 30 with suspicious BIRADS 4/5 Lesions
Patients who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with CEDM, CEMR and CEUS.
Interventions:
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||||
| Estimated Enrollment ICMJE |
50 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | June 2021 | ||||||
| Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 30 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03954015 | ||||||
| Other Study ID Numbers ICMJE | 18-003544 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Katrina N. Glazebrook, M.B., Ch.B., Mayo Clinic | ||||||
| Study Sponsor ICMJE | Mayo Clinic | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Mayo Clinic | ||||||
| Verification Date | November 2020 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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