NCT02133417

Non-Inferiority Quantitative Transmission Ultrasound Case Collection Study

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 287 (actual)
• Sponsor: QT Ultrasound LLC · Industry
• Sex: Female
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

Conduct a case collection study of breast imaging examinations from women with mammographically-detected breast lesions for the purpose of conducting subsequent Reader Studies.

Detailed description

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.

Conditions

• Mass Lesion

Interventions

Type	Name	Description
DEVICE	Quantitative Transmission Ultrasound	Quantitative Transmission Ultrasound (QTUS) as an automated breast ultrasound procedure for women who have a mammographically detected mass.

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-12-01
• Completion: 2016-01-01
• First posted: 2014-05-08
• Last updated: 2018-05-09

Locations

2 sites across 1 country: United States