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

Primary Purpose

Anatomic Stage 0 Breast Cancer AJCC v8, Bilateral Breast Carcinoma, Breast Ductal Carcinoma In Situ

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Intraoperative Imaging

Lumpectomy

About this trial

This is an interventional diagnostic trial for Anatomic Stage 0 Breast Cancer AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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.

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

Sites / Locations

Northwestern UniversityRecruiting
The University of KentuckyRecruiting
Washington University in St. LouisRecruiting
Cleveland ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (Volumetric Specimen Imager Device)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Sensitivity and specificity

The secondary endpoint of sensitivity and specificity of VSI-directed shaves will be determined using data from the surgical pathology report. Sensitivity will be calculated as the proportion of margins with pathologically identified tumor within a range of thresholds from 0-2 mm from the specimen edge directed for shaving by VSI interpretation. Specificity will be calculated as the proportion of margins with pathologically identified tumor above a range of thresholds from 0-2 mm from the specimen edge not directed for shaving by VSI interpretation.

Length of time

Length of time spent acquiring images with the VSI device is defined as the intraoperative time elapsed from the time when VSI imaging is started (i.e., capture of first image frame) to the time when VSI image reconstruction is completed (i.e., three-dimensional [3D] reconstruction image ready for viewing), as reported in the VSI device log file.

Volume of tissue excised

The volume of tissue excised in the main lumpectomy specimen and the volume of tissue excised in VSI-directed shaves is defined as the volume of the main lumpectomy specimen and of the VSI directed shave margins.

Full Information

NCT ID

NCT05545150

First Posted

September 14, 2022

Last Updated

November 30, 2022

Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT05545150

Brief Title

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

Official Title

Volumetric Lumpectomy Specimen Image Visualization for Intraoperatively Directing Cavity Shaves, a Phase II Study (VIVID)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 28, 2022 (Actual)

Primary Completion Date

July 1, 2024 (Anticipated)

Study Completion Date

July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Northwestern University

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Diagnostic (Volumetric Specimen Imager Device)

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Intraoperative Imaging

Intervention Description

Clarix Imaging Volumetric Specimen Imager

Intervention Type

Device

Intervention Name(s)

Lumpectomy

Other Intervention Name(s)

Lumpectomy of Breast, Partial Mastectomy

Intervention Description

Per standard of care (SOC)

Primary Outcome Measure Information:

Title

Positive margins

Description

Time Frame

Up to 2 months after breast conservation surgery

Secondary Outcome Measure Information:

Title

Sensitivity and specificity

Description

Time Frame

Up to 2 months after breast conservation surgery

Title

Length of time

Description

Time Frame

Up to 2 months after breast conservation surgery

Title

Volume of tissue excised

Description

Time Frame

Up to 2 months after breast conservation surgery

Other Pre-specified Outcome Measures:

Title

Retrospective analysis per published guidelines

Description

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.

Time Frame

Up to 2 months after breast conservation surgery

Title

Retrospective analysis per institutional practice

Description

Time Frame

Up to 2 months after breast conservation surgery

Title

Reoperation rate

Description

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.

Time Frame

Up to 2 months after breast conservation surgery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Study Coordinator

Phone

3126951301

cancer@northwestern.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Swati A Kulkarni, MD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Swati A. Kulkarni, M.D.

VIVIDstudy@northwestern.edu

First Name & Middle Initial & Last Name & Degree

Swati A. Kulkarni, M.D.

Facility Name

The University of Kentucky

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaoqin J. Wang, MD

Phone

859-323-5069

First Name & Middle Initial & Last Name & Degree

Xiaoqin J. Wang, MD

Facility Name

Washington University in St. Louis

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rebecca Aft, MD, PhD

Phone

314-747-0063

First Name & Middle Initial & Last Name & Degree

Rebecca Aft, MD, PhD

Facility Name

Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Stephanie Valente, DO

Phone

216-444-0769

First Name & Middle Initial & Last Name & Degree

Stephanie Valente, DO

12. IPD Sharing Statement

Learn more about this trial

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

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