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Anatomic Stage 0 Breast Cancer AJCC v8Phase 2NCT05545150

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

A Phase 2 study testing Intraoperative Imaging and Lumpectomy in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Bilateral Breast Carcinoma, run by Northwestern University at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Intraoperative Imaging and Lumpectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
113 participants
Where
4 sitesUnited States
Study dates
28 Nov 2022to 20 Mar 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Northwestern University

    Chicago, Illinois, 60611

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • The University of Kentucky

    Lexington, Kentucky, 40536

  • Washington University in St. Louis

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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:

  1. 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:

  1. 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.

Being tested
Intraoperative Imaging, Lumpectomy
Medical subject headings
Breast Carcinoma In Situ, Carcinoma, Intraductal, Noninfiltrating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intraoperative ImagingProcedure or surgery

    Clarix Imaging Volumetric Specimen Imager

  • LumpectomyDevice

    Also called Lumpectomy of Breast, Partial Mastectomy

    Per standard of care (SOC)

Study groups in NCT05545150
Study groupRoleWhat they receive
Diagnostic (Volumetric Specimen Imager Device)ExperimentalPatients undergo breast conservation surgery (lumpectomy or partial mastectomy) per standard care, and VSI intraoperative imaging is captured on the day of surgery.
Receives: Procedure: Intraoperative Imaging; Device: Lumpectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 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.

    Measured: Intraoperative

Secondary outcomes (4)

  1. Sensitivity

    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.

    Measured: Post-operative, up to 2 months after breast conservation surgery

  2. Specificity

    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.

    Measured: Post-operative, up to 2 months after breast conservation surgery

  3. 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.

    Measured: Intraoperative

  4. Volume of Tissue Excised

    The volume of tissue excised, including the main specimen and the VSI-directed shave margins.

    Measured: Post-operative, up to 2 months after breast conservation surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2022
  2. Study start28 Nov 2022
  3. Primary completion26 Jul 2024
  4. Study completion20 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05545150
Sponsor's protocol ID
NU 21B01
Other IDs
NCI-2022-02064, STU00214652, NU 21B01, P30CA060553, R44CA206801
Status last verified
Jul 2026
First submitted
14 Sep 2022
Last updated
19 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intraoperative Imaging and Lumpectomy in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Bilateral Breast Carcinoma, run by Northwestern University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive Margins (time frame: Intraoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05545150.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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