Status:
RECRUITING
Prospective Case Collection Study for New Mammography Technologies
Lead Sponsor:
Hologic, Inc.
Conditions:
Mammography
Eligibility:
FEMALE
35-100 years
Phase:
NA
Brief Summary
To evaluate the safety and efficacy of the proposed investigational device and assess its clinical utility in breast cancer screening and diagnosis to support continuing technology development of the ...
Eligibility Criteria
Inclusion
- Subject is female of any race and ethnicity.
- Subject is at least 35 years old.
- Subject is indicated for a screening or diagnostic mammogram or breast biopsy.
Exclusion
- Subject is pregnant or thinks she may be pregnant
- Subject has breast implants, cardiac pacemakers, nipple piercings, or IV ports in the mammography field of view.
- Subject previously participated in the study.
Key Trial Info
Start Date :
December 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
7500 Patients enrolled
Trial Details
Trial ID
NCT05199701
Start Date
December 10 2021
End Date
March 31 2026
Last Update
September 3 2025
Active Locations (15)
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1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
2
Southwest Medical Imaging
Gilbert, Arizona, United States, 85297
3
Scottsdale Medical Imaging LTD
Scottsdale, Arizona, United States, 85251
4
Miami Breast Institute
Coral Gables, Florida, United States, 33146