Clinical trial NCT04257799: Lumpectomy Specimen Margin Evaluation With Tomography and Structured Light Imaging
Official title: Lumpectomy Specimen Margin Evaluation With Tomography and Structured Light Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Female
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Trustees of Dartmouth College
First posted: 2020-02-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Sensitivity and Specificity of 3D tomography-SLI as measured by concurrence with standard of care 2-D mammography
timeFrame: Day of surgery
Secondary outcomes:
measure: Sensitivity and Specificity of 3D tomography alone in identifying true positive margins and true negative margins
timeFrame: Day of Surgery
measure: Sensitivity and Specificity of SLI alone in identifying true positive margins and true negative margins
timeFrame: Day of Surgery
measure: Sensitivity and Specificity of standard-of-care 2D specimen mammography
timeFrame: Day of Surgery
measure: Determine the logistics of use of the imaging system, software interface and specimen holder.
timeFrame: Day of Surgery
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: DHMC
name: Richard J Barth Jr., MD
role: PRINCIPAL_INVESTIGATOR
References: