Non-Inferiority Quantitative Transmission Ultrasound Case Collection Study (QTUS)
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|ClinicalTrials.gov Identifier: NCT02133417|
Recruitment Status : Completed
First Posted : May 8, 2014
Last Update Posted : May 9, 2018
|Condition or disease||Intervention/treatment|
|Mass Lesion||Device: Quantitative Transmission Ultrasound|
This is a prospective case collection study for the purpose of collecting cases for the subsequent Reader Studies at a minimum of two clinical sites.
Potential subjects will be recruited from a group of women who have undergone diagnostic mammography and demonstrate a mammographic lesion in at least one view. Approximately 300 women will be enrolled. Subjects will undergo QTUS following a diagnostic XRM with a mammographically-detected lesion(s) in at least one mammographic view and will have a lesion seen on HHUS corresponding to the XRM lesion(s). Potential Subjects will be eligible for enrollment at the time the corresponding lesion is identified on HHUS. All subjects will undergo an ultrasound guided aspiration/biopsy with cytology to determine whether the lesion is a cyst or solid.
Each study site is projected to collect approximately 75 cyst cases and 75 solid cases for a total of 150 cases, stratified across the four (4) recognized breast tissue density categories with at least 50% of cases from subjects with heterogeneous and extremely dense breast compositions. The composition of the cyst cases at each site is projected to consist of 25 simple cysts and 50 complicated and complex cysts for a total of 75 cyst cases. All enrolled subjects will undergo ultrasound guided aspiration or biopsy or surgical excision, as applicable for the index lesion. Cytologic or histologic results for all lesions will be performed and collected.
|Study Type :||Observational|
|Actual Enrollment :||287 participants|
|Official Title:||A Prospective Multi-center Case Collection Study of Breast Imaging Examinations From Women With Mammographically-detected Lesion(s) to Evaluate the Non-inferiority of Digital Mammography (XRM) and Quantitative Transmission Ultrasound (QTUS) Together Compared to XRM and Hand Held Ultrasound (HHUS) Together in the Evaluation of Lesion(s) Detected With Diagnostic Mammography.|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||January 2016|
Women with mammographically-detected breast lesions
Device: Quantitative Transmission Ultrasound
Quantitative Transmission Ultrasound (QTUS) as an automated breast ultrasound procedure for women who have a mammographically detected mass.
- The purpose of the case collection study is to collect mammographically-detected breast lesions seen in at least one mammographic view in the clinical setting and seen on HHUS, and confirmed by pathology. [ Time Frame: 12 months ]This is a prospective Case Collection study for the purpose of conducting subsequent Reader Studies. The primary objective for this prospective case collection study is to provide up to 300 cytology/pathology confirmed cases for subsequent Reader Studies.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02133417
|United States, District of Columbia|
|George Washington University Medical Center|
|Washington, District of Columbia, United States, 20037|
|United States, New York|
|Elizabeth Wende Breast Care, LLC|
|Rochester, New York, United States, 14620|
|Study Director:||Rajni Natesan, MD||Chief Medical Officer|