Clinical trial · Observational
Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System
NCT00267449CI-TRIAL-00000867unknownClinicalTrials.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)
The primary study endpoint -SoftScan adjunctive accuracy- will be used to test the hypothesis that the adjunctive combination of the SoftScan with x-ray mammography provides diagnostic accuracy that is significantly better than x-ray mammography alone.
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 |
|---|---|---|---|
| SoftScan Optical Breast Imaging System | Device | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Women between the ages of 20 and 80 years of age, who are either healthy or who are scheduled to undergo a tissue biopsy of surgical excision of a suspicious breast lesion for histopathologic diagnosis. Exclusion Criteria: For the Healthy Volunteers Population, * subjects with a history of minor breast procedures involving either breast; * subjects with a history of major breast procedures involving either breast; * subjects with a history of significant acute breast abnormalities involving either breast; and * subjects with a history of significant chronic breast abnormalities involving either breast; and For Referred For Biopsy Population, * subjects with a history of minor breast procedures involving either breast that were performed within 6 months prior to enrollment or which have not completed active healing at the time of enrollment; * subjects with a history of major breast procedures involving either breast; * subjects with a history of significant acute breast abnormalities involving either breast which have not completed active healing or resolution within 6 months prior to enrollment; and * subjects with a history of significant chronic breast abnormalities involving either breast.
References
Publications (1)
- BACKGROUNDIntes X. Time-domain optical mammography SoftScan: initial results. Acad Radiol. 2005 Aug;12(8):934-47. doi: 10.1016/j.acra.2005.05.006. PMID 16023382