An observational study in Breast Cancer Female, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-22.
Sponsored by Dartmouth-Hitchcock Medical Center · Observational
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.
On the day of surgery, the surgeon will remove the patient's cancerous tissue, and then in a separate room near the operating room, imaging staff will test it with the Structured Light Imaging system. The testing may take several extra minutes to capture the images. After this imaging, the surgeon will complete the surgery. Following surgery, and per routine medical care, the patient's breast tumor tissue sample will be sent to DHMC's lab for testing. The patient will see her primary doctor for standard surgery follow-up.
No additional imaging or testing will be required for this research study following the usual surgery.
Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.
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The investigators estimate that 100 women will be required. Based on the studies presented in the Introduction, the investigators expect 20% of breast cancer patients to have a positive margin.
Based on historical operative volumes, the investigators anticipate recruiting 2 breast cancer patients per week. Thus it will take one year to accrue 100 patients to the study.
Exclusion Criteria:
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.
Other: Structured Light Imaging (SLI) System
Investigation of SLI and Tomographic Imaging to see if they will identify cancer cells at the edge of tissue specimens removed during the operation.
Sensitivity and Specificity of 3D tomography-SLI as measured by concurrence with standard of care 2-D mammography
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.
Time frame: Day of surgery
Sensitivity and Specificity of 3D tomography alone in identifying true positive margins and true negative margins
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.
Time frame: Day of Surgery
Sensitivity and Specificity of SLI alone in identifying true positive margins and true negative margins
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.
Time frame: Day of Surgery
Sensitivity and Specificity of standard-of-care 2D specimen mammography
The investigators will calculate the sensitivity and specificity of standard-of-care 2D specimen mammography and compare that to the combination of 3D tomography and SLI. Sensitivity will be computed as TP/TP + FN results compared to pathology. Specificity will be computed as TN/TN + FP results compared to pathology.
Time frame: Day of Surgery
Determine the logistics of use of the imaging system, software interface and specimen holder.
The investigators will determine the logistics of use of the imaging system, software interface and specimen holder for possible future refinement.
Time frame: Day of Surgery
Plan to share: No
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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Dartmouth-Hitchcock Medical Center