Study of Monochromatic X-ray Mammography System
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40+
SponsorImagine Scientific, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female
40 yrs of age or older
Capable of giving informed consent
Prior history of mammography
Disqualifiers
Pregnancy
History of breast cancer surgery, including lumpectomy or mastectomy
Currently undergoing treatment for breast cancer
Previous breast augmentations
Trial design
Design model
Single group
Treatments tested in this trial
2-D Monochromatic X-ray Mammography System
DeviceMonochromatic x-ray mammography system produces superior images as compared to conventional 2-D and 3-D mammography while using a lower radiation dose.
Treatment groups
52 Participants
are divided into 1 treatment groupGroup A: Test device vs standard of careExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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. \[Likert scale 1-3. Higher score is a better outcome\]
Time frame
Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed)Secondary outcomes
1
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. \[Likert scale 1-3. Higher score is a better outcome\]
Time frame
End of visit 1 (or up to 7 days following visit 1, if needed)2
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. \[Likert scale 1-3. Higher score is a better outcome\]
Time frame
Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed)3
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. \[Likert scale 1-3. Higher score is a better outcome\]
Time frame
Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed)4
Patient satisfaction with monochromatic x-ray mammography system
Assess patient satisfaction with monochromatic x-ray mammography system. \[Likert scale 1-5. Higher score is a better outcome.\]
Time frame
Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Imagine Scientific, Inc.
Lead sponsor
Duke Health
Collaborator
Source ClinicalTrials.gov
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