Lumpectomy Specimen Margin Evaluation With Tomography and Structured Light Imaging

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Female
• Intervention / Treatment: Other: Structured Light Imaging (SLI) System

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women with breast cancer diagnosis; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Day of Surgery

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Trustees of Dartmouth College
• Investigators: Principal Investigator: Richard J Barth Jr., MD, DHMC

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 6, 2020
• Primary Completion (ACTUAL): March 16, 2022
• Study Completion (ACTUAL): March 16, 2022

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (ACTUAL): February 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 20, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: D19160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No