- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05545150
Volumetric Specimen Imager Device for the Intraoperative Imaging of Patients With Breast Carcinoma and Breast Ductal Carcinoma In Situ, The VIVID Study
Volumetric Lumpectomy Specimen Image Visualization for Intraoperatively Directing Cavity Shaves, a Phase II Study (VIVID)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern University
-
Contact:
- Swati A. Kulkarni, M.D.
- Email: VIVIDstudy@northwestern.edu
-
Principal Investigator:
- Swati A. Kulkarni, M.D.
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- Recruiting
- The University of Kentucky
-
Contact:
- Xiaoqin J. Wang, MD
- Phone Number: 859-323-5069
-
Principal Investigator:
- Xiaoqin J. Wang, MD
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University in St. Louis
-
Contact:
- Rebecca Aft, MD, PhD
- Phone Number: 314-747-0063
-
-
Ohio
-
Cleveland, Ohio, United States, 44195
- Recruiting
- Cleveland Clinic
-
Contact:
- Stephanie Valente, DO
- Phone Number: 216-444-0769
-
Principal Investigator:
- Stephanie Valente, DO
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Diagnostic (Volumetric Specimen Imager Device)
Patients undergo breast conservation surgery (lumpectomy or partial mastectomy) per standard care, and VSI intraoperative imaging is captured on the day of surgery.
|
Clarix Imaging Volumetric Specimen Imager
Per standard of care (SOC)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive margins
Time Frame: Up to 2 months after breast conservation surgery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity and specificity
Time Frame: Up to 2 months after breast conservation surgery
|
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.
|
Up to 2 months after breast conservation surgery
|
Length of time
Time Frame: Up to 2 months after breast conservation surgery
|
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.
|
Up to 2 months after breast conservation surgery
|
Volume of tissue excised
Time Frame: Up to 2 months after breast conservation surgery
|
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.
|
Up to 2 months after breast conservation surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Retrospective analysis per published guidelines
Time Frame: Up to 2 months after breast conservation surgery
|
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.
|
Up to 2 months after breast conservation surgery
|
Retrospective analysis per institutional practice
Time Frame: Up to 2 months after breast conservation surgery
|
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.
|
Up to 2 months after breast conservation surgery
|
Reoperation rate
Time Frame: Up to 2 months after breast conservation surgery
|
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.
|
Up to 2 months after breast conservation surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Swati A Kulkarni, MD, Northwestern University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Breast Diseases
- Neoplasms, Ductal, Lobular, and Medullary
- Carcinoma in Situ
- Breast Neoplasms
- Carcinoma
- Breast Carcinoma In Situ
- Carcinoma, Ductal
- Carcinoma, Intraductal, Noninfiltrating
- Carcinoma, Ductal, Breast
Other Study ID Numbers
- NU 21B01 (Other Identifier: Northwestern University)
- P30CA060553 (U.S. NIH Grant/Contract)
- NCI-2022-02064 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- STU00214652
- R44CA206801 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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