Clinical trial · Interventional
An Evaluation of a Self-contained Direct Digital Radiography System for Breast Specimen Imaging
NCT01379092CI-TRIAL-00006520unknownN/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)
The objective of this study is to evaluate the image quality and operation of a self-contained direct digital radiography system for breast specimen imaging.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bioptics, Faxitron, and Full Field Digital Mammography (FFDM) Selenia | Device | — | UNRESOLVED |
| Trident Specimen Radiography System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Breast biopsy specimen imaging & comparison of image quality
- description
- Each subject's explanted tissue will serve as both the control (standard analysis) and the experimental analysis of the quality of the images.
- interventionNames
- Device: Trident Specimen Radiography System
- Device: Bioptics, Faxitron, and Full Field Digital Mammography (FFDM) Selenia
Primary outcomes (1)
- measure
- Breast biopsy specimen will be imaged on standard of care device and on the Trident Specimen Radiography device to compare quality of images.
- timeFrame
- 1 Day
- description
- Images will be taken at time of biopsy with no additional follow-up time for patient.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Breast specimens acquired through MIBB or Surgical techniques arriving for specimen imaging Exclusion Criteria: * Breast specimens that are larger than12 x 14 cm.
References
Publications (2)
- BACKGROUNDSilverstein MJ, Lagios MD, Recht A, Allred DC, Harms SE, Holland R, Holmes DR, Hughes LL, Jackman RJ, Julian TB, Kuerer HM, Mabry HC, McCready DR, McMasters KM, Page DL, Parker SH, Pass HA, Pegram M, Rubin E, Stavros AT, Tripathy D, Vicini F, Whitworth PW. Image-detected breast cancer: state of the art diagnosis and treatment. J Am Coll Surg. 2005 Oct;201(4):586-97. doi: 10.1016/j.jamcollsurg.2005.05.032. No abstract available. PMID 16183499
- BACKGROUNDKaufman CS, Jacobson L, Bachman BA, Kaufman LB, Mahon C, Gambrell LJ, Seymour R, Briscoe J, Aulisio K, Cunningham A, Opstad F, Schnell N, Robertson J, Oliver L. Intraoperative digital specimen mammography: rapid, accurate results expedite surgery. Ann Surg Oncol. 2007 Apr;14(4):1478-85. doi: 10.1245/s10434-006-9126-5. Epub 2007 Jan 18. PMID 17235716