Clinical trial · Observational
Lumpectomy Specimen Margin Evaluation With Tomography and Structured Light Imaging
- 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 purpose of this study is to test a new surgical imaging system called "Structured Light Imaging (SLI)." This system is designed to examine tissue removed during breast cancer surgery to see whether the tissue's edges contain cancer. The current standard of practice is to remove the breast tumor tissue and send the tissue to the lab for analysis following surgery. One in five women (in the US) must later return for a second surgery to remove cancer cells that the lab found remaining in the tissue. In this study, researchers hope that the new SLI system may detect the cancer cells in the tissue's edges by imaging at the time of surgery. If successful, in the future we may use this system to improve entire cancer removal at the time of surgery, and reduce the need to perform a second surgery to remove additional breast tissue.
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 Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Structured Light Imaging (SLI) System | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Women with breast cancer diagnosis
- description
- Women with diagnosis of invasive breast cancer based on pre-surgical biopsy, and scheduled for breast-conserving surgery in the Dartmouth-Hitchcock (DH) Outpatient Surgical Center.
- interventionNames
- Other: Structured Light Imaging (SLI) System
Primary outcomes (1)
- measure
- Sensitivity and Specificity of 3D tomography-SLI as measured by concurrence with standard of care 2-D mammography
- timeFrame
- Day of surgery
- description
- Two surfaces (anterior and posterior) will be evaluated by SLI and 6 surfaces (anterior, posterior, medial, lateral, cranial, and caudal) will be evaluated by 3D tomography. Four surfaces are evaluated by standard-of-care 2-dimensional specimen mammography: medial, lateral, cranial and caudal to evaluate for the presence of cancer at the margin. Since anterior and posterior surfaces will be evaluated by both 3D tomography and SLI, an anterior or posterior margin will be considered positive only if it is positive by both 3D tomography and SLI. Otherwise the margin will be considered negative. Sensitivity will be computed as True Positive (TP)/TP + False Negative (FN) results, compared to pathology. Specificity will be computed as True Negative (TN)/TN + False Positive (FP) results, compared to pathology.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Females 18 years of age or older. 2. Histologic diagnosis of invasive breast cancer based on pre-surgical core biopsy. 3. Scheduled for breast conserving surgery in the Dartmouth-Hitchcock (DH) Outpatient Surgical Center 4. Ability to give an informed consent. Exclusion Criteria: 1. Patients who will have an expected specimen size greater than the specimen holder (i.e. \> 10 X 10 X 5 cm). 2. Prisoners and cognitively impaired adults.
References
Publications (0)
Data not yet available