Clinical trial · Interventional
Computed Radiography (CR) Data Collection for Mammography Computer Aided Detection (CAD)
NCT00610831CI-TRIAL-00031472withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding Issues
Summary
Brief summary (as posted)
The objective of this study is to collect an image library of diagnostic digital mammograms using the Carestream CR mammography system from patients who have histological-conformed breast cancer to demonstrate the clinical feasibility of this system for detection of breast cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DIRECTVIEW CR Mammography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DirectView CR Mammography
- description
- Each subject will have routine clinical care imaging obtained and 4 standard mammogram views (RMLO, RCC, LMLO, LCC) using CR mammography. If routine mammograms were obtained on a day previous to enrollment in the study, those images (4 views; 2 views for mastectomy patients) will not be repeated for this study; only the CR images will be obtained.
- interventionNames
- Device: DIRECTVIEW CR Mammography
Primary outcomes (1)
- measure
- To collect mammogram from patients with breast cancer using the Carestream Mammo CR device.
- timeFrame
- at completion of the study
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Requirements * Women age 40 to 85 * Recommended for biopsy and BI-RADS assessment of category 4 (suspicious abnormality) or 5 (highly suggestive of malignancy) * Able to have MLO and CC views taken * Good general health * Able and willing to provide a written Informed Consent Exclusion Requirements * Under age 40 * Pregnant or suspicious of being pregnant * Breast implants * Breasts too large to be adequately positioned on a 24 x 30 cassette * Personal history of breast cancer treated with a lumpectomy * Unable or unwilling to provide a written Informed Consent form
References
Publications (0)
Data not yet available
No reference posted for this study.