Lumpectomy Specimen Margin Evaluation With Tomography and Structured Light Imaging

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Dartmouth-Hitchcock Medical Center
Updated on 19 February 2024
cancer
breast cancer
cancer surgery
lumpectomy
invasive breast cancer
core needle biopsy
breast-conserving surgery
breast tumor

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.

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.

Details
Condition Breast Cancer Female
Age 18-100 years
Treatment Structured Light Imaging (SLI) System
Clinical Study IdentifierNCT04257799
SponsorDartmouth-Hitchcock Medical Center
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Females 18 years of age or older
Histologic diagnosis of invasive breast cancer based on pre-surgical core biopsy
Scheduled for breast conserving surgery in the Dartmouth-Hitchcock (DH) Outpatient Surgical Center
Ability to give an informed consent

Exclusion Criteria

Patients who will have an expected specimen size greater than the specimen holder (i.e. > 10 X 10 X 5 cm)
Prisoners and cognitively impaired adults
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