Last reviewed · How we verify
NCT03047122
Detection of Breast Lesions by Automatic Breast US
trial in Ultrasonography in 1,200 participants. Status unknown.
31 December 2017
Quick facts
| Lead sponsor | Assuta Medical Center |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 1,200 |
| Start date | 1 March 2017 |
| Primary completion | 31 December 2017 |
| Estimated completion | 31 December 2018 |
| Sites | 1 location across Israel |
Conditions studied
- Ultrasonography — all drugs for Ultrasonography →
- Breast — all drugs for Breast →
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:
- PubMed search for NCT03047122
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Assuta Medical Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03047122 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Assuta Medical Center
- Last refreshed: 21 March 2017
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