MammographyNCT05199701
Prospective Case Collection Study for New Mammography Technologies
A study testing Mammography in people with Mammography, run by Hologic, Inc. at 15 sites in United States.
Trial 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 investigational technology. Read more about this study
- Who is it for?
- Ages 35 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mammography
- What is being tested?
- Mammography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,500 participants
- Where
- 15 sitesUnited States
- Study dates
- 10 Dec 2021to 5 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Washington Radiology
Arlington, Virginia, 22201
Progressive Radiology
Bel Air, Maryland, 21014
Solis Mammography Burleson
Burleson, Texas, 76028
Solis Mammography Columbus
Columbus, Ohio, 43214
Miami Breast Institute
Coral Gables, Florida, 33146
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
Southwest Medical Imaging
Gilbert, Arizona, 85297
Corewell Health
Grand Rapids, Michigan, 49503
Solis Mammography Greensboro
Greensboro, North Carolina, 27401
Baptist Health
Louisville, Kentucky, 40207
Diagnostic Centers of America Palm Beach Gardens
Palm Beach Gardens, Florida, 33410
Elizabeth Wendy Breast Care
Rochester, New York, 14620
Scottsdale Medical Imaging LTD
Scottsdale, Arizona, 85251
Washington Radiology
Sterling, Virginia, 20166
Diagnostic Centers of America West Palm Beach
West Palm Beach, Florida, 33401
About this study
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.
- Conditions
- Mammography
- Being tested
- Mammography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MammographyDevice
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 group | Role | What they receive |
|---|---|---|
| Investigational Mammogram Exam | Experimental | Not described Receives: Device: Mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically acceptable image quality of the Investigational Device.
Questionnaire will be used to measure outcomes
Measured: 4 years
Mammograms can be safety acquired on the Investigational Device.
Will be determined using the AE assessment.
Measured: 4 years
Secondary outcomes (2)
The ease of positioning and usability of the Investigational Device.
Questionnaire will be used to measure outcomes
Measured: 4 years
Subject assessment of comfort of the Investigational Device.
Questionnaire will be used to measure outcomes
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start10 Dec 2021
- Primary completion5 Nov 2026 (estimated)
- Study completion5 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MammographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hologic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199701
- Sponsor's protocol ID
- 20-08
- Status last verified
- Jun 2026
- First submitted
- 16 Dec 2021
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: To protect participant privacy and comply with the IRB. The IRB did not approved the secondary use of IPD at the time the protocol was approved.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Case Collection Study for New Mammography Technologies
- ClinicalTrials.gov ID
- NCT05199701
- Acronym / sponsor ID
- 20-08
- Conditions
- Mammography
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 7,500 participants (estimated)
- Lead sponsor
- Hologic, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 5 Nov 2026 (estimated)
- Study completion
- 5 Nov 2026 (estimated)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational Mammogram Exam | Experimental | Device: Mammography |
Who may qualify
- Ages
- 35 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MammographyAll subjects who are indicated for a screening or diagnostic mammogram or breast biopsy will undergo an investigational exam in a new mammography device. | Device | Investigational Mammogram Exam |
Primary outcome
Clinically acceptable image quality of the Investigational Device.
Time frame: 4 years
Questionnaire will be used to measure outcomes
Mammograms can be safety acquired on the Investigational Device.
Time frame: 4 years
Will be determined using the AE assessment.
2 secondary outcomes
The ease of positioning and usability of the Investigational Device.
Time frame: 4 years
Subject assessment of comfort of the Investigational Device.
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No. To protect participant privacy and comply with the IRB. The IRB did not approved the secondary use of IPD at the time the protocol was approved.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mammography in people with Mammography, run by Hologic, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically acceptable image quality of the Investigational Device. (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026; AzTrials last refreshed its copy on 29 Oct 2026.