Study Results
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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NOT_YET_RECRUITING
NA
52 participants
INTERVENTIONAL
2025-10-31
2026-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Test device vs standard of care
Demonstrate that a 2-D monochromatic x-ray mammography system can produce mammographic images using lower radiation dose, yet not inferior to conventional mammography.
2-D Monochromatic X-ray Mammography System
Monochromatic x-ray mammography system produces superior images as compared to conventional 2-D and 3-D mammography while using a lower radiation dose.
Interventions
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2-D Monochromatic X-ray Mammography System
Monochromatic x-ray mammography system produces superior images as compared to conventional 2-D and 3-D mammography while using a lower radiation dose.
Eligibility Criteria
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Inclusion Criteria
* 40 yrs of age or older
* Capable of giving informed consent
* Prior history of mammography
Exclusion Criteria
* History of breast cancer surgery, including lumpectomy or mastectomy
* Currently undergoing treatment for breast cancer
* Previous breast augmentations
40 Years
FEMALE
No
Sponsors
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Duke Health
OTHER
Imagine Scientific, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lars Grimm, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Health
Locations
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Duke Cancer Center
Durham, North Carolina, United States
Countries
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Facility Contacts
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Other Identifiers
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Pro00115443
Identifier Type: -
Identifier Source: org_study_id
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