Lumpectomy Specimen Margin Evaluation With Tomography and Structured Light Imaging

Overview

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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 2021

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Sensitivity and Specificity of 3D tomography-SLI as measured by concurrence with standard of care 2-D mammography
    • Time Frame: Day of surgery
    • 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.

Secondary Measures

  • Sensitivity and Specificity of 3D tomography alone in identifying true positive margins and true negative margins
    • Time Frame: Day of Surgery
    • 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.
  • Sensitivity and Specificity of SLI alone in identifying true positive margins and true negative margins
    • Time Frame: Day of Surgery
    • 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.
  • Sensitivity and Specificity of standard-of-care 2D specimen mammography
    • Time Frame: Day of Surgery
    • 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.
  • Determine the logistics of use of the imaging system, software interface and specimen holder.
    • Time Frame: Day of Surgery
    • The investigators will determine the logistics of use of the imaging system, software interface and specimen holder for possible future refinement.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dartmouth-Hitchcock Medical Center
  • Collaborator
    • Trustees of Dartmouth College
  • Provider of Information About this Clinical Study
    • Principal Investigator: Richard J. Barth,Jr., Chief, Section of General Surgery – Dartmouth-Hitchcock Medical Center
  • Overall Official(s)
    • Richard J Barth Jr., MD, Principal Investigator, DHMC
  • Overall Contact(s)
    • Richard J Barth Jr., MD, 800-639-6918, Richard.J.Barth.Jr@Hitchcock.org

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.