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OpenTrials
Active, Not Recruiting

NCT Number: NCT05199701

Prospective Case Collection Study for New Mammography Technologies

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Mammography

Age range

35 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Clinically acceptable image quality of the Investigational Device.

    Time frame: 4 years

    Questionnaire will be used to measure outcomes

  2. Mammograms can be safety acquired on the Investigational Device.

    Time frame: 4 years

    Will be determined using the AE assessment.

Secondary outcomes

  1. The ease of positioning and usability of the Investigational Device.

    Time frame: 4 years

    Questionnaire will be used to measure outcomes

  2. Subject assessment of comfort of the Investigational Device.

    Time frame: 4 years

    Questionnaire will be used to measure outcomes

Sponsors and collaborators

Lead sponsor

Hologic, Inc.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2022
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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