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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00716482 |
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Date of registration:
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14/07/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Ultrasound Elastography of Breast Lesions
BE1 |
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Scientific title:
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Assessment of the Clinical Value of SuperSonic Shear Wave Elastography in the Ultrasonic Evaluation of Breast Lesions |
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Date of first enrolment:
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July 2008 |
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Target sample size:
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1681 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00716482 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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France
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Germany
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Italy
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United Kingdom
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United States
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Contacts
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Name:
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David O Cosgrove, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hammersmith Hospitals NHS Trust |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patients who have been referred to a breast ultrasound because of a positive physical
palpation and/or positive mammograms and/or positive ultrasound and/or positive MRI.
- female
- age 21 or older
- provide informed consent
Exclusion Criteria:
- Women who are unwilling or unable to provide informed consent
- Women with breast implants
- Women with superficial lesions or lesions on skin (with the most superficial surface
of the lesion within 5 mm of the skin surface)
- Women who are pregnant or breastfeeding
- Women who are undergoing chemotherapy or radiotherapy for any cancer
- Women with previous breast conserving surgery on the breast of interest Note: Previous
excision of a benign lesion 4 cm or more away from the suspected lesion does not
constitute an exclusion criterion.
Age minimum:
21 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Neoplasms
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Primary Outcome(s)
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Estimates of Effect of Selectively Upgrading BIRADS Category 3 and Downgrading BIRADS 4a Masses Based on SWE Features. Overall Specificity and Sensitivity of BI-RADS Score Using Conventional B-mode Ultrasound vs. B-mode + Certain SWE Characteristics
[Time Frame: 2 years]
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Secondary Outcome(s)
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Interobserver Agreement of B Mode Ultrasound and SWE Features
[Time Frame: performed on the same day, after study completion]
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Intraobserver Reliability of Quantitative SWE Measurements
[Time Frame: performed on the same day, within 2 years from study start date]
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Qualitative Intraobserver Reproducibility of SWE Related to Homogeneity Feature
[Time Frame: performed on the same day, within 2 years from study start date]
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Secondary ID(s)
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A00152-53
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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