Prospective Case Collection Study for New Mammography Technologies

NCT ID: NCT05199701

Last Updated: 2025-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

7500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-10

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Mammography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Investigational Mammogram Exam

Group Type EXPERIMENTAL

Mammography

Intervention Type 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.

Interventions

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Mammography

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hologic, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Site Status ACTIVE_NOT_RECRUITING

Southwest Medical Imaging

Gilbert, Arizona, United States

Site Status ACTIVE_NOT_RECRUITING

Scottsdale Medical Imaging LTD

Scottsdale, Arizona, United States

Site Status ACTIVE_NOT_RECRUITING

Miami Breast Institute

Coral Gables, Florida, United States

Site Status RECRUITING

Diagnostic Centers of America Palm Beach Gardens

Palm Beach Gardens, Florida, United States

Site Status TERMINATED

Diagnostic Centers of America West Palm Beach

West Palm Beach, Florida, United States

Site Status TERMINATED

Baptist Health

Louisville, Kentucky, United States

Site Status ACTIVE_NOT_RECRUITING

Progressive Radiology

Bel Air, Maryland, United States

Site Status ACTIVE_NOT_RECRUITING

Corewell Health

Grand Rapids, Michigan, United States

Site Status ACTIVE_NOT_RECRUITING

Elizabeth Wendy Breast Care

Rochester, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Solis Mammography Greensboro

Greensboro, North Carolina, United States

Site Status ACTIVE_NOT_RECRUITING

Solis Mammography Columbus

Columbus, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Solis Mammography Burleson

Burleson, Texas, United States

Site Status ACTIVE_NOT_RECRUITING

Washington Radiology

Arlington, Virginia, United States

Site Status ACTIVE_NOT_RECRUITING

Washington Radiology

Sterling, Virginia, United States

Site Status ACTIVE_NOT_RECRUITING

Countries

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United States

Central Contacts

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Santina Wendling

Role: CONTACT

202-821-9375

Alexis Cooper

Role: CONTACT

281-868-1140

Facility Contacts

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Geena Thomas

Role: primary

Other Identifiers

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20-08

Identifier Type: -

Identifier Source: org_study_id

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