Trial Outcomes & Findings for Volumetric Specimen Imager Device for the Intraoperative Imaging of Patients With Breast Carcinoma and Breast Ductal Carcinoma In Situ, The VIVID Study (NCT NCT05545150)
NCT ID: NCT05545150
Last Updated: 2026-08-19
Results Overview
The primary endpoint of main specimen positive margins identified by volumetric specimen imager (VSI) interpretation and excised intraoperatively is defined as the percentage 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.
COMPLETED
PHASE2
113 participants
Intraoperative
2026-08-19
Participant Flow
All patients from four academic institutions signed a written consent prior to participation in the study. Eligibility criteria for the prospective trial included women undergoing BCS with planned localization and intraoperative imaging for the management of invasive breast cancer (IBC) and/or ductal carcinoma in situ (DCIS.) Exclusion criteria included patients undergoing re-excision and those patients with tumors exceeding the size of the specimen container.
A total of 113 participants were enrolled into the study. For 13 of these, VSI was not used during surgery due to scheduling challenges. A total of 100 participants underwent the complete study protocol and had observed outcomes.
Participant milestones
| Measure |
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.
Intraoperative Imaging: Clarix Imaging Volumetric Specimen Imager
Lumpectomy: Per standard of care (SOC)
|
|---|---|
|
Overall Study
STARTED
|
113
|
|
Overall Study
COMPLETED
|
100
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
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.
Intraoperative Imaging: Clarix Imaging Volumetric Specimen Imager
Lumpectomy: Per standard of care (SOC)
|
|---|---|
|
Overall Study
Scheduling challenges for VSI use
|
13
|
Baseline Characteristics
Volumetric Specimen Imager Device for the Intraoperative Imaging of Patients With Breast Carcinoma and Breast Ductal Carcinoma In Situ, The VIVID Study
Baseline characteristics by cohort
| Measure |
Diagnostic (Volumetric Specimen Imager Device)
n=100 Participants
Patients undergo breast conservation surgery (lumpectomy or partial mastectomy) per standard care, and VSI intraoperative imaging is captured on the day of surgery.
Intraoperative Imaging: Clarix Imaging Volumetric Specimen Imager
Lumpectomy: Per standard of care (SOC)
|
|---|---|
|
Age, Continuous
|
62 Years
n=298 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=298 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=298 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=298 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=298 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=298 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=298 Participants
|
|
Race (NIH/OMB)
White
|
81 Participants
n=298 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=298 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=298 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=298 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
91 Participants
n=298 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=298 Participants
|
|
Histological diagnosis
Invasive ductal carcinoma (IDC)
|
53 Participants
n=298 Participants
|
|
Histological diagnosis
Invasive lobular carcinoma (ILC) with or without ductal carcinoma in situ (DCIS) component
|
5 Participants
n=298 Participants
|
|
Histological diagnosis
Mixed IDC and ILC
|
9 Participants
n=298 Participants
|
|
Histological diagnosis
DCIS with or without microinvasion
|
20 Participants
n=298 Participants
|
|
Histological diagnosis
IDC with a DCIS component
|
13 Participants
n=298 Participants
|
PRIMARY outcome
Timeframe: IntraoperativeThe primary endpoint of main specimen positive margins identified by volumetric specimen imager (VSI) interpretation and excised intraoperatively is defined as the percentage 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.
Outcome measures
| Measure |
Diagnostic (Volumetric Specimen Imager Device)
n=100 Participants
Patients undergo breast conservation surgery (lumpectomy or partial mastectomy) per standard care, and VSI intraoperative imaging is captured on the day of surgery.
Intraoperative Imaging: Clarix Imaging Volumetric Specimen Imager
Lumpectomy: Per standard of care (SOC)
|
|---|---|
|
Positive Margins
|
9 Participants
|
SECONDARY outcome
Timeframe: Post-operative, up to 2 months after breast conservation surgeryPopulation: Margins identified as positive in pathology reports
The secondary endpoint of sensitivity of VSI-directed shaves will be determined using data from the surgical pathology report. Sensitivity will be calculated as the percentage 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.
Outcome measures
| Measure |
Diagnostic (Volumetric Specimen Imager Device)
n=27 Margins
Patients undergo breast conservation surgery (lumpectomy or partial mastectomy) per standard care, and VSI intraoperative imaging is captured on the day of surgery.
Intraoperative Imaging: Clarix Imaging Volumetric Specimen Imager
Lumpectomy: Per standard of care (SOC)
|
|---|---|
|
Sensitivity
|
11 Margins
|
SECONDARY outcome
Timeframe: Post-operative, up to 2 months after breast conservation surgeryPopulation: Margins identified as negative in pathology reports
The secondary endpoint of specificity of VSI-directed shaves will be determined using data from the surgical pathology report. Specificity will be calculated as the percentage 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.
Outcome measures
| Measure |
Diagnostic (Volumetric Specimen Imager Device)
n=573 Negative margins
Patients undergo breast conservation surgery (lumpectomy or partial mastectomy) per standard care, and VSI intraoperative imaging is captured on the day of surgery.
Intraoperative Imaging: Clarix Imaging Volumetric Specimen Imager
Lumpectomy: Per standard of care (SOC)
|
|---|---|
|
Specificity
|
450 Negative margins
|
SECONDARY outcome
Timeframe: IntraoperativeLength 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.
Outcome measures
| Measure |
Diagnostic (Volumetric Specimen Imager Device)
n=100 Participants
Patients undergo breast conservation surgery (lumpectomy or partial mastectomy) per standard care, and VSI intraoperative imaging is captured on the day of surgery.
Intraoperative Imaging: Clarix Imaging Volumetric Specimen Imager
Lumpectomy: Per standard of care (SOC)
|
|---|---|
|
Length of Time
|
178 seconds
Interval 172.0 to 203.0
|
SECONDARY outcome
Timeframe: Post-operative, up to 2 months after breast conservation surgeryThe volume of tissue excised, including the main specimen and the VSI-directed shave margins.
Outcome measures
| Measure |
Diagnostic (Volumetric Specimen Imager Device)
n=100 Participants
Patients undergo breast conservation surgery (lumpectomy or partial mastectomy) per standard care, and VSI intraoperative imaging is captured on the day of surgery.
Intraoperative Imaging: Clarix Imaging Volumetric Specimen Imager
Lumpectomy: Per standard of care (SOC)
|
|---|---|
|
Volume of Tissue Excised
|
48.7 cm^3
Interval 3.08 to 401.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Post-operative, up to 2 months after breast conservation surgeryTo 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.
Outcome measures
| Measure |
Diagnostic (Volumetric Specimen Imager Device)
n=100 Participants
Patients undergo breast conservation surgery (lumpectomy or partial mastectomy) per standard care, and VSI intraoperative imaging is captured on the day of surgery.
Intraoperative Imaging: Clarix Imaging Volumetric Specimen Imager
Lumpectomy: Per standard of care (SOC)
|
|---|---|
|
Reoperation Rate
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: IntraoperativeOn a margin level, the frequency of final positive margins when margins from the main specimen and margins from the VSI directed shaves were evaluated collectively.
Outcome measures
| Measure |
Diagnostic (Volumetric Specimen Imager Device)
n=599 Margins
Patients undergo breast conservation surgery (lumpectomy or partial mastectomy) per standard care, and VSI intraoperative imaging is captured on the day of surgery.
Intraoperative Imaging: Clarix Imaging Volumetric Specimen Imager
Lumpectomy: Per standard of care (SOC)
|
|---|---|
|
Positive Margins (Per Margin)
|
20 Margins
|
Adverse Events
Diagnostic (Volumetric Specimen Imager Device)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Denise Scholtens, Professor of Biostatistics and Informatics
Northwestern University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place