Status:
COMPLETED
Clinical Evaluation of CEM-guided Biopsy
Lead Sponsor:
Parc de Salut Mar
Collaborating Sponsors:
General Electric
Conditions:
Contrast Enhanced Mammography-guided Biopsy
Eligibility:
FEMALE
18+ years
Brief Summary
CEM-guided biopsy is an optional accessory of Senographe Pristina intended to provide accurate location of lesions in the breast in three dimensions, using information obtained from Contrast Enhanced ...
Detailed Description
Pristina Serena CEM is an option to the standard Pristina Serena breast biopsy unit. It is designed to allow the accurate localization of lesions in the breast in three dimensions, using information o...
Eligibility Criteria
Inclusion
- Adult women presenting with clinical indication for a breast biopsy procedure after a positive abnormal CEM or MRI examination, and considered eligible for this procedure as per standard of care.
- Are able and willing to comply with study procedures
- Are able and willing to provide written informed consent to participate
Exclusion
- Findings not accessible for stereotactic guidance biopsy
- Are currently lactating
- Have breast implants
Key Trial Info
Start Date :
October 8 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 6 2021
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT05250674
Start Date
October 8 2019
End Date
October 6 2021
Last Update
February 22 2022
Active Locations (1)
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1
Hospital del Mar - Parc de Salut Mar
Barcelona, Catalonia, Spain, 08003