Volumetric Specimen Imager Device for the Intraoperative Imaging of Patients With Breast Carcinoma and Breast Ductal Carcinoma In Situ, The VIVID Study

Last updated: February 4, 2025
Sponsor: Northwestern University
Overall Status: Active - Not Recruiting

Phase

2

Condition

Carcinoma

Ductal Carcinoma In Situ (Dcis)

Breast Cancer

Treatment

Intraoperative Imaging

Lumpectomy

Clinical Study ID

NCT05545150
NU 21B01
P30CA060553
R44CA206801
NU 21B01
STU00214652
NCI-2022-02064
  • Ages > 18
  • Female

Study Summary

This clinical trial assesses if the use of a three-dimensional imaging device called the Clarix Imaging Volumetric Specimen Imager (VSI) can help guide and assist surgeons in identifying and removing all positive margins while in the operating room (intraoperative imaging) for patients with breast cancer and breast ductal carcinoma in situ. Breast conservation surgery or lumpectomy is a standard of care (routine) procedure that removes the tumor and a rim of surrounding normal tissue (margins) while leaving as much normal breast tissue as possible. A margin that does not contain tumor cells is called a negative margin and tells the surgeon that the primary tumor has been removed. A positive margin contains tumor cells at or near the edge of the tissue removed. As part of standard of care, surgeons take two-dimensional x-ray images of the tissue that has been removed in the operating room to assess if there is any additional tissue that should be shaved (removed) to get a negative margin. After the surgery is over, the tissue is examined once again by a pathologist in a laboratory to determine if there are any small pieces of tumor left in the margin that were not visible during surgery. If residual tumor is detected in the margin, a reoperation may be required to remove additional tissue until the tumor has been completely removed from the margin. Diagnostic procedures, such as intraoperative volumetric specimen imaging may reduce the rate of reoperation of for patients who previously underwent lumpectomy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Women with invasive breast cancer and/or ductal carcinoma in situ (DCIS) who will beundergoing breast conservation surgery, consisting of a lumpectomy or partialmastectomy procedure

  • Patients must be planning and able to undergo breast conservation surgery withplanned localization (any localization device is eligible) and intraoperativeimaging for the management of invasive breast cancer and/or DCIS.

  • Patients must have histologically confirmed invasive breast cancer, ductal carcinomain situ (DCIS), or invasive breast cancer with a DCIS component.

  • The invasive breast cancer and/or DCIS lesion must have been visualized onmammography/ digital breast tomosynthesis (DBT), ultrasound (US), or magneticresonance imaging (MRI).

  • Note: Patients with mammographically occult lesions are eligible, provided thelesion can be visualized using MRI or US.

  • Patients must be women who are >= 18 years of age.

  • NOTE: Males and children under the age of 18 are not included in this studybecause the treatment paradigms for these groups are aggressive and routinelyinclude mastectomy, whereas the present study is an investigation of breastconservation.

  • The patient (or the patient's legally authorized representative if the patient hasimpaired decision-making capacity) must have the ability to understand and providevoluntary written informed consent to participate in this study, prior toregistration.

  • Patients who have received neoadjuvant chemotherapy for the treatment of breastcancer are eligible

  • Patients with bilateral breast cancer and/or multicentric disease are eligible.

  • Note: For these patients, the VSI device will only be used on a single lesion

  • Subjects with a prior or concurrent malignancy whose natural history or treatmentdoes not have the potential to interfere with the safety or efficacy assessment ofthe investigational intervention for this trial are eligible.

Exclusion

Exclusion Criteria:

  • Patients undergoing re-excision for invasive breast cancer or DCIS are not eligible

  • Patients who are expected to have an excised lumpectomy specimen that is larger than 9 cm x 9 cm x 7 cm are not eligible

  • Note: The specimen size limitation for the VSI device is 9 cm x 9 cm x 7 cm (length x width x height).

  • Patients must not have a physical or psychiatric illness, condition, or socialcircumstance that the investigator feels would interfere with study compliance orwould compromise the patient's safety or study endpoints.

Study Design

Total Participants: 113
Treatment Group(s): 2
Primary Treatment: Intraoperative Imaging
Phase: 2
Study Start date:
November 28, 2022
Estimated Completion Date:
July 01, 2026

Study Description

PRIMARY OBJECTIVE:

I. To determine if intraoperative use of the volumetric specimen imager (VSI) device during breast conservation surgery in women with invasive breast cancer and/or ductal carcinoma in situ (DCIS) allows surgeons to accurately identify margin status, such that =<10% of patients have positive margins on final surgical pathology of the main specimen that were unidentified by VSI image interpretation for excision.

SECONDARY OBJECTIVES:

I. To calculate the sensitivity and specificity of VSI-directed shaves compared to the lumpectomy specimen pathology, when VSI device imaging is used intraoperatively to identify close tumor margins for directed cavity shaving in women with invasive breast cancer and/or DCIS who are undergoing breast conservation surgery.

II. To calculate the length of time spent acquiring images with the VSI device, at the time of breast conservation surgery in women with invasive breast cancer and/or DCIS.

III. To calculate the volume of tissue excised in the main lumpectomy specimen and the volume of tissue excised in VSI-directed cavity shaves, when excising tumor margins at the time of breast conservation surgery in women with invasive breast cancer and/or DCIS.

OTHER PRE-SPECIFIED OBJECTIVES:

I. To compare the estimated final positive margin rate for lumpectomy with VSI-directed cavity shaving to the historical final positive margin rate for lumpectomy with standard of care margin assessment, wherein 'positive margin' is defined per published guidelines.

II. To compare the estimated final positive margin rate for lumpectomy with VSI-directed cavity shaving to the historical final positive margin rate for lumpectomy with standard of care margin assessment, wherein 'positive margin' is defined per institutional practice. III. To compare the estimated reoperation rate for patients undergoing lumpectomy with VSI-directed cavity shaving to the historical reoperation rate for patients who previously underwent lumpectomy with standard of care margin assessment.

EXPLORATORY OBJECTIVE:

I. To retrospectively evaluate the sensitivity and specificity of interpretation of shave margin VSI images to determine the feasibility of imaging shaved margins with VSI to further direct cavity shaves.

OUTLINE:

Patients undergo breast conservation surgery (lumpectomy or partial mastectomy) per standard care, and VSI intraoperative imaging is captured on the day of surgery.

After completion of study, patients are followed up for 2 months.

Connect with a study center

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • The University of Kentucky

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Washington University in St. Louis

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

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