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NCT Number: NCT04257799

Lumpectomy Specimen Margin Evaluation With Tomography and Structured Light Imaging

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.

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Key information

Conditions

Breast Cancer Female

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Trustees of Dartmouth College

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 6, 2020
Registry last updated
Jun 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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