Clinical trial · Interventional
A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins
NCT01372631CI-TRIAL-00049988completedN/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 goal of this research is to further develop novel optical assay systems for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bench-top optical spectrometer | Device | — | UNRESOLVED |
| High resolution microendoscope | Device | — | UNRESOLVED |
| miniature spectral imaging system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Pressure assessment
- description
- 30 patients undergoing lumpectomy, mastectomy or reduction mammoplasty will be enrolled to assess the ideal pressure that should be applied when taking optical measurements.
- interventionNames
- Device: miniature spectral imaging system
- Device: Bench-top optical spectrometer
- type
- EXPERIMENTAL
- label
- Random and Systematic Errors
- description
- 40 patients undergoing lumpectomy or mastectomy will be enrolled to assess the random and systematic errors of the miniature spectral imaging system.
- interventionNames
- Device: miniature spectral imaging system
- Device: Bench-top optical spectrometer
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing a reduction mammoplasty OR * Patients undergoing a lumpectomy mastectomy for the treatment of an invasive or non-invasive breast malignancy * Age \> 18 * Clinically detectable disease either by physical examination or radiographic studies * Patients of all ethnic and gender groups will be included. Protocol accrual will be reviewed annually to include a determination of minority and gender representation. If accrual demonstrates under-representation of any group with comparison to disease incidence in that group, appropriate measures will be undertaken to increase participation of patients of that minority or gender group * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients considered in "vulnerable" populations.
References
Publications (0)
Data not yet available
No reference posted for this study.