Breast ImagingNCT07219797
Study of Monochromatic X-ray Mammography System
A study testing 2-D Monochromatic X-ray Mammography System in people with Breast Imaging and Breast Cancer, run by Imagine Scientific, Inc. at 1 site in United States.
Trial summary
A research study to find out if an investigational mammography machine is effective in producing high-quality images using a lower radiation dose than traditional mammography. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Imaging, Breast Cancer
- What is being tested?
- 2-D Monochromatic X-ray Mammography System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Apr 2027
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- 40 yrs of age or older
- Capable of giving informed consent
- Prior history of mammography
Who cannot join
- Pregnancy
- History of breast cancer surgery, including lumpectomy or mastectomy
- Currently undergoing treatment for breast cancer
- Previous breast augmentations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Duke Cancer Center
Durham, North Carolina, 27710
Amy Cuddington, 919-684-3296, amy.cuddington@duke.edu
Lars Grimm, MD
About this study
A research study to find out if an investigational mammography machine is effective in producing high-quality images using a lower radiation dose than traditional mammography.
Read the detailed description
Prospective, single-arm, non-blinded, comparative/observational study.
Phase 1: Verify operation of monochromatic system and optimize the monochromatic energies and exposure times for a range of breast thicknesses.
Phase 2: Test the performance of the monochromatic system in comparison to traditional 2-D mammography for a range of clinical/imaging scenarios.
Phase 3: Test the performance of the monochromatic system using reduced breast compression.
- Conditions
- Breast Imaging, Breast Cancer
- Being tested
- 2-D Monochromatic X-ray Mammography System
- Keywords
- Mammography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-D Monochromatic X-ray Mammography SystemDevice
Monochromatic x-ray mammography system produces superior images as compared to conventional 2-D and 3-D mammography while using a lower radiation dose.
| Study group | Role | What they receive |
|---|---|---|
| Test device vs standard of care | Experimental | Demonstrate that a 2-D monochromatic x-ray mammography system can produce mammographic images using lower radiation dose, yet not inferior to conventional mammography. Receives: Device: 2-D Monochromatic X-ray Mammography System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Noninferiority of a 2-D monochromatic X-ray mammography system compared to conventional mammography
Demonstrate that a 2-D monochromatic X-ray mammography system can produce mammographic images using lower radiation dose (at least 20% less than conventional mammography), yet, not inferior to conventional mammography. [Likert scale 1-3. Higher score is a better outcome]
Measured: Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed)
Secondary outcomes (4)
Relevant pathologies identified by monochromatic-based x-ray as compared to conventional mammography
Assess ability of monochromatic-based X-ray mammography to identify relevant pathologies in subjects with dense breast issue (BI-RADS density categories C and D) otherwise not detected in scans produced with conventional mammography. [Likert scale 1-3. Higher score is a better outcome]
Measured: End of visit 1 (or up to 7 days following visit 1, if needed)
Lower breast compression with monochromatic-based x-ray mammography
Assess ability of monochromatic-based x-ray mammography to produce quality images with lower breast compression. [Likert scale 1-3. Higher score is a better outcome]
Measured: Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed)
Quality of images produced by monochromatic-based x-ray mammography at lower radiation dose.
Demonstrate ability of monochromatic-based mammography to produce quality images at radiation doses below maximum FDA-approved radiation dose. [Likert scale 1-3. Higher score is a better outcome]
Measured: Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed)
Patient satisfaction with monochromatic x-ray mammography system
Assess patient satisfaction with monochromatic x-ray mammography system. [Likert scale 1-5. Higher score is a better outcome.]
Measured: Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2025
- Study startJun 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ImagingStudies 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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imagine Scientific, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke Health
- Responsible party
- Sponsor
- Investigators
- Lars Grimm, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219797
- Sponsor's protocol ID
- Pro00115443
- Status last verified
- Oct 2025
- First submitted
- 11 Sep 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data is confidential and proprietary. Sponsor permission is required to share data.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Monochromatic X-ray Mammography System
- ClinicalTrials.gov ID
- NCT07219797
- Acronym / sponsor ID
- Pro00115443
- Conditions
- Breast Imaging, Breast Cancer
- Keywords
- Mammography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Imagine Scientific, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Duke Health
- Study start
- Jun 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 22 Oct 2025 (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.
A research study to find out if an investigational mammography machine is effective in producing high-quality images using a lower radiation dose than traditional mammography.
Detailed description
Prospective, single-arm, non-blinded, comparative/observational study.
Phase 1: Verify operation of monochromatic system and optimize the monochromatic energies and exposure times for a range of breast thicknesses.
Phase 2: Test the performance of the monochromatic system in comparison to traditional 2-D mammography for a range of clinical/imaging scenarios.
Phase 3: Test the performance of the monochromatic system using reduced breast compression.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test device vs standard of care | Experimental | Device: 2-D Monochromatic X-ray Mammography SystemDemonstrate that a 2-D monochromatic x-ray mammography system can produce mammographic images using lower radiation dose, yet not inferior to conventional mammography. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- 40 yrs of age or older
- Capable of giving informed consent
- Prior history of mammography
Key exclusion criteria (4 listed)
- Pregnancy
- History of breast cancer surgery, including lumpectomy or mastectomy
- Currently undergoing treatment for breast cancer
- Previous breast augmentations
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 |
|---|---|---|
| 2-D Monochromatic X-ray Mammography SystemMonochromatic x-ray mammography system produces superior images as compared to conventional 2-D and 3-D mammography while using a lower radiation dose. | Device | Test device vs standard of care |
Primary outcome
Noninferiority of a 2-D monochromatic X-ray mammography system compared to conventional mammography
Time frame: Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed)
Demonstrate that a 2-D monochromatic X-ray mammography system can produce mammographic images using lower radiation dose (at least 20% less than conventional mammography), yet, not inferior to conventional mammography. [Likert scale 1-3. Higher score is a better outcome]
4 secondary outcomes
Relevant pathologies identified by monochromatic-based x-ray as compared to conventional mammography
Time frame: End of visit 1 (or up to 7 days following visit 1, if needed)
Lower breast compression with monochromatic-based x-ray mammography
Time frame: Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed)
Quality of images produced by monochromatic-based x-ray mammography at lower radiation dose.
Time frame: Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed)
Patient satisfaction with monochromatic x-ray mammography system
Time frame: Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed)
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 25 Mar 2026.
- Individual participant dataSharing planned: No. Data is confidential and proprietary. Sponsor permission is required to share data.
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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.
Lars Grimm, MD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-D Monochromatic X-ray Mammography System in people with Breast Imaging and Breast Cancer, run by Imagine Scientific, Inc. at 1 site 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 4 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: opening soon, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Noninferiority of a 2-D monochromatic X-ray mammography system compared to conventional mammography (time frame: Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed)). 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 25 Mar 2026.