Lumpectomy Specimen Margin Evaluation With Tomography and Structured Light Imaging

NCT ID: NCT04257799

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-06
• Study Completion Date: 2022-03-16

Brief Summary

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.

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.

Conditions

Breast Cancer Female

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Structured Light Imaging (SLI) System

Intervention Type: OTHER

Investigation of SLI and Tomographic Imaging to see if they will identify cancer cells at the edge of tissue specimens removed during the operation.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Trustees of Dartmouth College

OTHER

Sponsor Role: collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Richard J. Barth,Jr.

Chief, Section of General Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard J Barth Jr., MD

Role: PRINCIPAL_INVESTIGATOR

DHMC

Locations

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Countries

United States

Other Identifiers

D19160

Identifier Type: -

Identifier Source: org_study_id