Breast ScreeningNCT06636539
Prospective Case Collection Study of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational Device
A study testing CEM Software in New Mammography Device in people with Breast Screening, run by Hologic, Inc. at 2 sites in United States.
Trial summary
This is a prospective, multi-center image case collection study to acquire de-identified contrast-enhanced breast images on a mammography device to support continuing software technology development. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Breast Screening
- What is being tested?
- CEM Software in New Mammography Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Oct 2024to 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 years and older
- Women only
- No healthy volunteers
- 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 has a suspicious finding or breast abnormality on a screening or diagnostic mammogram and is indicated for a diagnostic exam or a biopsy procedure.
- Subject is able to read, understand, and sign the study-specific informed consent form (ICF) after the nature of the study has been fully explained to them.
Who cannot join
- Subject is unable or unwilling to undergo informed consent or subject who requires a Legally Authorized Representative (LAR) for Informed Consent.
- Subject has breast implants, cardiac pacemakers, nipple piercings, or IV ports in the mammography field of view in the breast of interest.
- Subject has had an interventional procedure in the same breast as the suspicious finding within the last six (6) months
- Subject is pregnant or presumed to be pregnant.
- Subject is breastfeeding.
- Subject is actively being treated for cancer of any type with chemotherapy
Show all 10Show fewer
- Subject is suspected to be at risk of complications from the iodinated contrast agent. These include contra-indications of standard iodinated contrast agents, such as the subject having renal insufficiency) and the subject being on dialysis.
- Subject has had a prior reaction to iodinated contrast; thus, a known allergy to iodinated contrast.
- Subject has had a prior reaction to gadolinium contrast agents; thus, a known allergy to gadolinium contrast.
- Subject who, based on the physician's judgment, may be at increased risk for complications associated with renal function, anticoagulant therapy, or bleeding disorders.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Solis Mammography Memorial Village
Houston, Texas, 77024
Washington Radiology Sterling
Sterling, Virginia, 20166
About this study
This is a prospective, multi-center image case collection study to acquire de-identified contrast-enhanced breast images on a mammography device to support continuing software technology development. Eligible subjects include women at least 35 years old with a suspicious finding or breast abnormality on a screening or diagnostic mammogram who are indicated for a diagnostic exam or a biopsy procedure.
Read the detailed description
Contrast-Enhanced Mammography (CEM) is intended to be an extension for diagnostic mammography. It is a technique in which digital 2D mammography is supplemented with the use of intravenous iodinated contrast administration to facilitate cancer detection. The imaging acquired under a contrast agent has preferential uptake in regions of increased vascularity providing complement information for diagnosis. The CEM software application that will be tested is similar to the marketed software I-View™ 2.0 and is intended for use as an adjunct following mammography and/or ultrasound exams as a diagnostic work-up to localize and further characterize a known or suspected lesion.
Thus, to assess the clinical efficacy of the Hologic CEM software I-View in a new mammography device, Sponsor is conducting a prospective case collection study to support the verification and validation of image quality assessments.
- Conditions
- Breast Screening
- Being tested
- CEM Software in New Mammography Device
- Keywords
- CEM, Contrast-Enhanced Mammography, Contrast, Diagnostic mammogram, Mammography, Mammogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEM Software in New Mammography DeviceDevice
All subjects enrolled in the study will undergo a CEM exam.
| Study group | Role | What they receive |
|---|---|---|
| CEM Investigational Exam | Experimental | Not described Receives: Device: CEM Software in New Mammography Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects (cases) with lesions
Number of subjects with contrast-enhanced breast images containing lesions as assessed by radiologists' image quality review
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start14 Oct 2024
- 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 Breast ScreeningStudies 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
- 75 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
- NCT06636539
- Sponsor's protocol ID
- 20-43
- Status last verified
- Jun 2026
- First submitted
- 7 Oct 2024
- Last updated
- 22 Jun 2026
- Results posted
- 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 of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational Device
- ClinicalTrials.gov ID
- NCT06636539
- Acronym / sponsor ID
- 20-43
- Conditions
- Breast Screening
- Keywords
- CEM, Contrast-Enhanced Mammography, Contrast, Diagnostic mammogram, Mammography, Mammogram
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Hologic, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 5 Nov 2026 (estimated)
- Study completion
- 5 Nov 2026 (estimated)
- First posted
- 10 Oct 2024 (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.
This is a prospective, multi-center image case collection study to acquire de-identified contrast-enhanced breast images on a mammography device to support continuing software technology development. Eligible subjects include women at least 35 years old with a suspicious finding or breast abnormality on a screening or diagnostic mammogram who are indicated for a diagnostic exam or a biopsy procedure.
Detailed description
Contrast-Enhanced Mammography (CEM) is intended to be an extension for diagnostic mammography. It is a technique in which digital 2D mammography is supplemented with the use of intravenous iodinated contrast administration to facilitate cancer detection. The imaging acquired under a contrast agent has preferential uptake in regions of increased vascularity providing complement information for diagnosis. The CEM software application that will be tested is similar to the marketed software I-View™ 2.0 and is intended for use as an adjunct following mammography and/or ultrasound exams as a diagnostic work-up to localize and further characterize a known or suspected lesion.
Thus, to assess the clinical efficacy of the Hologic CEM software I-View in a new mammography device, Sponsor is conducting a prospective case collection study to support the verification and validation of image quality assessments.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CEM Investigational Exam | Experimental | Device: CEM Software in New Mammography Device |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is female of any race and ethnicity.
- Subject is at least 35 years old
- Subject has a suspicious finding or breast abnormality on a screening or diagnostic mammogram and is indicated for a diagnostic exam or a biopsy procedure.
- Subject is able to read, understand, and sign the study-specific informed consent form (ICF) after the nature of the study has been fully explained to them.
Key exclusion criteria (10 listed)
- Subject is unable or unwilling to undergo informed consent or subject who requires a Legally Authorized Representative (LAR) for Informed Consent.
- Subject has breast implants, cardiac pacemakers, nipple piercings, or IV ports in the mammography field of view in the breast of interest.
- Subject has had an interventional procedure in the same breast as the suspicious finding within the last six (6) months
- Subject is pregnant or presumed to be pregnant.
- Subject is breastfeeding.
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 |
|---|---|---|
| CEM Software in New Mammography DeviceAll subjects enrolled in the study will undergo a CEM exam. | Device | CEM Investigational Exam |
Primary outcome
Number of subjects (cases) with lesions
Time frame: 18 months
Number of subjects with contrast-enhanced breast images containing lesions as assessed by radiologists' image quality review
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CEM Software in New Mammography Device in people with Breast Screening, run by Hologic, Inc. at 2 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 4 inclusion and 10 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 2 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?
Number of subjects (cases) with lesions (time frame: 18 months). 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.