Clinical trial · Interventional
Study of Monochromatic X-ray Mammography System
NCT07219797CI-TRIAL-00106458not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Imaging | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2-D Monochromatic X-ray Mammography System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Test device vs standard of care
- description
- Demonstrate that a 2-D monochromatic x-ray mammography system can produce mammographic images using lower radiation dose, yet not inferior to conventional mammography.
- interventionNames
- Device: 2-D Monochromatic X-ray Mammography System
Primary outcomes (1)
- measure
- Noninferiority of a 2-D monochromatic X-ray mammography system compared to conventional mammography
- timeFrame
- Enrollment to end of visit 1 (or up to 7 days following visit 1, if needed)
- description
- 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. \[Likert scale 1-3. Higher score is a better outcome\]
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Female * 40 yrs of age or older * Capable of giving informed consent * Prior history of mammography Exclusion Criteria: * Pregnancy * History of breast cancer surgery, including lumpectomy or mastectomy * Currently undergoing treatment for breast cancer * Previous breast augmentations
References
Publications (0)
Data not yet available
No reference posted for this study.