Lumpectomy Specimen Margin Evaluation With Tomography and Structured Light Imaging

NCT04257799 | Completed DMC

• 1 other identifier: D19160
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Sensitivity and Specificity of 3D tomography alone in identifying true positive margins and true negative margins

  Day of Surgery

• Sensitivity and Specificity of SLI alone in identifying true positive margins and true negative margins

  Day of Surgery

• Sensitivity and Specificity of standard-of-care 2D specimen mammography

  Day of Surgery

• Determine the logistics of use of the imaging system, software interface and specimen holder.

  Day of Surgery

Study Arms (1)

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

Interventions

Structured Light Imaging (SLI) System 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.

Women with breast cancer diagnosis

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Trustees of Dartmouth College: collaborator

Study Sites (1)

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Richard J Barth Jr., MD

  DHMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Section of General Surgery

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 6, 2020
• Study Start: February 6, 2020
• Primary Completion: March 16, 2022
• Study Completion: March 16, 2022
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)