Clinical trial · Interventional
Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy
- 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 the proposed research is to develop new diagnostic modalities based on optical spectroscopy (auto fluorescence, absorption, and scattering) for the diagnosis of breast cancer and test its performance as an adjunct to core needle biopsy. For the surgery part of the study, all patients scheduled to have a mastectomy or lumpectomy for the treatment of breast cancer will be asked if they would be willing to participate in this study. For the core needle biopsy part of the study, patients with a higher pre-probability of cancer (based on mammography) will be recruited to increase the number of patients with malignant lesions and enrolled in this investigation.
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 |
|---|---|---|---|
| High Resolution Microendoscope | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Core needle biopsy
- description
- Patients needing a needle biopsy of a breast mass
- interventionNames
- Device: High Resolution Microendoscope
- type
- PLACEBO_COMPARATOR
- label
- Reduction mammoplasty
- description
- Any patients scheduled for a reduction mammoplasty who would like to participate in a study to better understand breast cancer
- interventionNames
- Device: High Resolution Microendoscope
Primary outcomes (1)
- measure
- Optical signatures
- timeFrame
- Day of procedure (less than 10 minutes)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients having a needle biopsy of a breast mass Exclusion Criteria: * none
References
Publications (0)
Data not yet available