Clinical trial · Interventional
Study to Compare the Diagnostic Accuracy of Nuance Full-Field Digital Mammography to Screen-Film Mammography
NCT00942396CI-TRIAL-00004979withdrawnPhase 3ClinicalTrials.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): FDA changed classification of device and no longer requires this type of clinical data
Summary
Brief summary (as posted)
Evaluate the diagnostic accuracy of the Planmed Sophie Nuance Full Field Digital Mammography (FFDM) X-ray System compared to screen-film mammography (SFM) in the 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 |
|---|---|---|---|
| Full Field Digital Mammogram (Planmed Sophie Nuance) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- mammography
- description
- Women must be at least 40 years of age, presenting for routine breast cancer screening or presenting with one or both breasts scored 4 or 5 on the BI-RADS scale as a result of SFM either for routine breast cancer screening or for follow-up or diagnostic mammography
- interventionNames
- Device: Full Field Digital Mammogram (Planmed Sophie Nuance)
Primary outcomes (1)
- measure
- Area under ROC curve based on subjects' maximum POM scores; sensitivity based on subjects' maximum BI-RADS scores with 4 or higher as positive for cancer; and specificity based on subjects maximum BI-RADS scores with 4 or higher as positive for cancer
- timeFrame
- Approximately one year after completion of study.
Secondary outcomes (7)
- measure
- area under the ROC curve based on the maximum POM score per subject-breast
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject is 40 years of age or older 2. Subject is presenting for routine breasts cancer screening (Cohort I) OR Subject has one or both breasts scored 4 or 5 on the BI-RADS scale as a result of SFM either for routine breast cancer screening or for follow-up or diagnostic mammography (Cohort II) 3. Subject's schedule permits the SFM and the FFDM to be performed no more than 30 days apart and with no intervention between the exams 4. Subject will provide prospective, written informed consent 5. Subject is considered capable of complying with study procedures including a willingness to return for a one-year follow-up exam - Exclusion Criteria: 1. Subject is pregnant or possibly pregnant or planning pregnancy within the next 15 months 2. Subject has undergone a breast augmentation or breast implant? Has subject had any of the following breast procedures? Fine needle or cyst aspiration NOT Eligible if within past year Biopsy Not Eligible if within past year Lumpectomy (for breast cancer) Mastectomy (for breast cancer) Radiation therapy Breast reconstruction Breast reduction Not Eligible if within past year 3. Subject has had an invasive breast procedure or operation within the past year 4. Subject has significant existing breast trauma 5. Subject has a history of breast cancer treated with operation or radiation 6. Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data
References
Publications (0)
Data not yet available
No reference posted for this study.