Trial Title:
Volumetric Specimen Imager Device for the Intraoperative Imaging of Patients With Breast Carcinoma and Breast Ductal Carcinoma In Situ, The VIVID Study
NCT ID:
NCT05545150
Condition:
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
Conditions: Official terms:
Carcinoma
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Breast Carcinoma In Situ
Carcinoma, Ductal, Breast
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Intraoperative Imaging
Description:
Clarix Imaging Volumetric Specimen Imager
Arm group label:
Diagnostic (Volumetric Specimen Imager Device)
Intervention type:
Device
Intervention name:
Lumpectomy
Description:
Per standard of care (SOC)
Arm group label:
Diagnostic (Volumetric Specimen Imager Device)
Other name:
Lumpectomy of Breast
Other name:
Partial Mastectomy
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Northwestern University
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Recruiting
Contact:
Last name:
Swati A. Kulkarni, M.D.
Email:
VIVIDstudy@northwestern.edu
Investigator:
Last name:
Swati A. Kulkarni, M.D.
Email:
Principal Investigator
Facility:
Name:
The University of Kentucky
Address:
City:
Lexington
Zip:
40536
Country:
United States
Status:
Recruiting
Contact:
Last name:
Xiaoqin J. Wang, MD
Phone:
859-323-5069
Investigator:
Last name:
Xiaoqin J. Wang, MD
Email:
Principal Investigator
Facility:
Name:
Washington University in St. Louis
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rebecca Aft, MD, PhD
Phone:
314-747-0063
Investigator:
Last name:
Rebecca Aft, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Stephanie Valente, DO
Phone:
216-444-0769
Investigator:
Last name:
Stephanie Valente, DO
Email:
Principal Investigator
Start date:
November 28, 2022
Completion date:
July 1, 2024
Lead sponsor:
Agency:
Northwestern University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Northwestern University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05545150
