Last reviewed · How we verify

NCT03047122

Detection of Breast Lesions by Automatic Breast US

Status unknown Last updated 21 March 2017
What this trial tests

trial in Ultrasonography in 1,200 participants. Status unknown.

Timeline
1 March 2017
Primary endpoint
31 December 2017
31 December 2018

Quick facts

Lead sponsorAssuta Medical Center
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment1,200
Start date1 March 2017
Primary completion31 December 2017
Estimated completion31 December 2018
Sites1 location across Israel

Conditions studied

Sponsor

Assuta Medical Center

Who can join

Adults 25 to 99, female only, with Ultrasonography or Breast. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Mammography is considered the standard imaging method for breast cancer screening, and is known to result in reduced mortality from breast cancer. However, the diagnostic yield of mammography depends particularly on breast tissue density, with sensitivity as low as 30-48% in dense-breast women. Ultrasound is an attractive adjunct imaging method to mammography as it is widely accessible, relatively inexpensive and well-tolerated by patients. The addition of hand-held ultrasound to mammography has been demonstrated to significantly increase breast cancer detection in women with dense breasts. It is however dependent on the expertise and skill of the operator. In recent years, the FDA has approved the use of the automated breast ultrasound (ABUS) for use in screening of women with dense breast. Unlike handheld ultrasound, the ABUS is relatively simple to use, necessitating less technical training, and results in higher reproducibility. The research aim is to evaluation of automated breast ultrasound (ABUS) regarding the detection and classification of breast lesions, compared to hand-held ultrasound, according to the American College of Radiology Breast Imaging-Reporting and Data System (BI-RADS) classification. The investigator will also evaluate parameters regarding patients' comfort, workflow, and duration of image interpretation.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Ultrasonography

Currently open trials in the same condition.

Other Assuta Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03047122.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing