Prospective Case Collection Study for New Mammography Technologies

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Hologic, Inc.
Study ID
NCT05199701
Status
Recruiting
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Conditions

  • Mammography

Eligibility Criteria

Sex
FEMALE
Age
35 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Mammography — DEVICE
    All subjects who are indicated for a screening or diagnostic mammogram or breast biopsy will undergo an investigational exam in a new mammography device.

Study Details

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 investigational technology.

Key Dates

Start date
Dec 10, 2021
Status verified
Aug 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
7,500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: Investigational Mammogram Exam

Primary Outcome Measure

Clinically acceptable image quality of the Investigational Device. [ Time Frame: 4 years ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234-
Southwest Medical ImagingGilbertArizona85297-
Scottsdale Medical Imaging LTDScottsdaleArizona85251-
Miami Breast InstituteCoral GablesFlorida33146
Geena Thomas
Diagnostic Centers of America Palm Beach GardensPalm Beach GardensFlorida33410-
Diagnostic Centers of America West Palm BeachWest Palm BeachFlorida33401-
Baptist HealthLouisvilleKentucky40207-
Progressive RadiologyBel AirMaryland21014-
Corewell HealthGrand RapidsMichigan49503-
Elizabeth Wendy Breast CareRochesterNew York14620-
Solis Mammography GreensboroGreensboroNorth Carolina27401-
Solis Mammography ColumbusColumbusOhio43214-
Solis Mammography BurlesonBurlesonTexas76028-
Washington RadiologyArlingtonVirginia22201-
Washington RadiologySterlingVirginia20166-

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Banner MD Anderson Cancer Center· Gilbert, AZSouthwest Medical Imaging· Gilbert, AZScottsdale Medical Imaging LTD· Scottsdale, AZMiami Breast Institute· Coral Gables, FLDiagnostic Centers of America Palm Beach Gardens· Palm Beach Gardens, FLDiagnostic Centers of America West Palm Beach· West Palm Beach, FL

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