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

NCT05545150 | Active Not Recruiting Phase 2 DMC FDA Device

• 5 other identifiers: NU 21B01NCI-2022-02064STU00214652P30CA060553R44CA206801
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Anatomic Stage 0 Breast Cancer AJCC v8; Bilateral Breast Carcinoma; Breast Ductal Carcinoma In Situ; Invasive Breast Carcinoma; Multicentric Breast Carcinoma; Prognostic Stage 0 Breast Cancer AJCC v8

Outcome Measures

Primary Outcomes (1)

• Positive margins

  The primary endpoint of main specimen positive margins identified by volumetric specimen imager (VSI) interpretation and excised intraoperatively is defined as the proportion of patients with at least one main specimen positive margin that was not excised intraoperatively by a VSI-directed shave. A positive margin is defined as ink on tumor (1 or more tumor cells touching the edge of the lumpectomy specimen) for invasive breast cancer and for invasive breast cancer with a ductal carcinoma in situ (DCIS) component; ink within 2 mm of the edge of the lumpectomy specimen for DCIS, and ink within 2 mm of the lumpectomy specimen for DCIS with microinvasion.

  Up to 2 months after breast conservation surgery

Secondary Outcomes (3)

• Sensitivity and specificity

  Up to 2 months after breast conservation surgery

• Length of time

  Up to 2 months after breast conservation surgery

• Volume of tissue excised

  Up to 2 months after breast conservation surgery

Other Outcomes (3)

• Retrospective analysis per published guidelines

  Up to 2 months after breast conservation surgery

• Retrospective analysis per institutional practice

  Up to 2 months after breast conservation surgery

• Reoperation rate

  Up to 2 months after breast conservation surgery

Study Arms (1)

Diagnostic (Volumetric Specimen Imager Device)

EXPERIMENTAL

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

Procedure: Intraoperative Imaging; Device: Lumpectomy

Interventions

Intraoperative Imaging PROCEDURE

Clarix Imaging Volumetric Specimen Imager

Diagnostic (Volumetric Specimen Imager Device)

Lumpectomy DEVICE

Per standard of care (SOC)

Also known as: Lumpectomy of Breast, Partial Mastectomy

Diagnostic (Volumetric Specimen Imager Device)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with invasive breast cancer and/or ductal carcinoma in situ (DCIS) who will be undergoing breast conservation surgery, consisting of a lumpectomy or partial mastectomy procedure
• Patients must be planning and able to undergo breast conservation surgery with planned localization (any localization device is eligible) and intraoperative imaging for the management of invasive breast cancer and/or DCIS.
• Patients must have histologically confirmed invasive breast cancer, ductal carcinoma in situ (DCIS), or invasive breast cancer with a DCIS component.
• The invasive breast cancer and/or DCIS lesion must have been visualized on mammography/ digital breast tomosynthesis (DBT), ultrasound (US), or magnetic resonance imaging (MRI).
• Note: Patients with mammographically occult lesions are eligible, provided the lesion 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 study because the treatment paradigms for these groups are aggressive and routinely include mastectomy, whereas the present study is an investigation of breast conservation.
• The patient (or the patient's legally authorized representative if the patient has impaired decision-making capacity) must have the ability to understand and provide voluntary written informed consent to participate in this study, prior to registration.
• Patients who have received neoadjuvant chemotherapy for the treatment of breast cancer 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 treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational intervention for this trial are eligible.

You may not qualify if:

• 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 social circumstance that the investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints.

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Northwestern University

Chicago, Illinois, 60611, United States

Location

The University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Study Officials

• Swati A Kulkarni, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 19, 2022
• Study Start: November 28, 2022
• Primary Completion: July 26, 2024
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

US (4)