Intraoperative 3D Imaging for Breast Cancer

Not currently recruiting at 4 trial locations

Overseen By Study Coordinator

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Northwestern University

Disqualifiers: Re-excision, Large specimen size, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new 3D imaging device, the Clarix Imaging Volumetric Specimen Imager (VSI), to assist surgeons in identifying and removing all cancerous tissue during breast conservation surgeries. The goal is to minimize additional surgeries by ensuring no tumor cells remain at the edges of removed tissue. Women with breast cancer, particularly those planning to undergo lumpectomy or partial mastectomy, are suitable candidates if their tumors are visible on imaging tests like mammograms or MRIs. This approach aims to enhance surgery outcomes and reduce the likelihood of further surgery. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to advancements in breast cancer surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Clarix Imaging Volumetric Specimen Imager (VSI) is safe for intraoperative use in breast cancer surgery?

Research has shown that the Clarix Imaging Volumetric Specimen Imager (VSI) aids surgeons during breast cancer surgery by providing full 3D images. This device offers a comprehensive view of the removed tissue, helping ensure the removal of all cancer cells during the operation.

For safety, the VSI uses x-rays to create these images. X-rays are commonly used in medical imaging and are generally considered safe when used properly. The FDA has approved the device for making 2D and 3D x-ray images, indicating it is well-tolerated and poses no unusual safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Clarix Imaging Volumetric Specimen Imager (VSI) because it offers a new approach to imaging during breast cancer surgeries. Unlike traditional methods that rely on 2D imaging, VSI provides 3D imaging to help surgeons ensure they’ve removed all the cancerous tissue right during the operation. This real-time, 3D visualization could potentially reduce the need for additional surgeries by giving surgeons more accurate information on the spot. This advancement aims to improve surgical outcomes and the overall treatment experience for patients undergoing breast conservation surgery.

What evidence suggests that the Clarix Imaging Volumetric Specimen Imager is effective for breast cancer surgery?

Studies have shown that 3D X-ray imaging, such as the Clarix Imaging Volumetric Specimen Imager (VSI), helps surgeons clearly see the edges of tissue removed during breast cancer surgery. This tool provides a complete view, making it easier to spot any remaining cancer cells immediately. Research suggests that using this device during surgery can lead to better outcomes than traditional 2D imaging, potentially reducing the need for a second surgery. The VSI allows surgeons to view thin slices of tissue from all angles, ensuring more thorough tumor removal. This method could make surgeries more effective and reduce the chances of cancer returning. ^{1 2 3 4 6}

Who Is on the Research Team?

Swati A Kulkarni, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for women over 18 with invasive breast cancer or ductal carcinoma in situ (DCIS) who are undergoing a lumpectomy. They must have visible lesions on imaging tests and can have received chemotherapy. Women with bilateral/multicentric disease or other malignancies that don't affect the trial's safety/efficacy can join, but not if they need large tissue removal or re-excision.

Inclusion Criteria

I have had chemotherapy before surgery for breast cancer.

I have breast cancer and will have surgery to remove part of my breast.

I have been diagnosed with a type of breast cancer.

Exclusion Criteria

My lumpectomy specimen is expected to be smaller than 9x9x7 cm.

I am not having a re-excision for breast cancer.

Note: The specimen size limitation for the VSI device is 9 cm x 9 cm x 7 cm (length x width x height)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Imaging

Patients undergo breast conservation surgery and VSI intraoperative imaging is captured on the day of surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

8 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Clarix Imaging Volumetric Specimen Imager (VSI)

Trial Overview The study is testing a new three-dimensional imaging device called Clarix Imaging VSI during surgery to see if it helps surgeons remove all cancerous tissue more effectively than current two-dimensional x-ray methods, potentially reducing the need for additional surgeries.

How Is the Trial Designed?

Group I: Diagnostic (Volumetric Specimen Imager Device) Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The developed optical visible spectral imaging platform demonstrated a high signal to noise ratio (SNR) greater than 100 and less than 15% error in measuring optical properties, indicating its potential effectiveness in distinguishing between negative and close/positive surgical margins during breast conserving surgery.

The system showed a sensing depth of 0.5-2.2 mm, aligning with the pathologic criterion for clear margins, and exhibited reproducibility with a low coefficient of variation, although improvements in imaging speed are needed for practical intra-operative use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance metrics of an optical spectral imaging system for intra-operative assessment of breast tumor margins. Bydlon, TM., Kennedy, SA., Richards, LM., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05545150

Volumetric Specimen Imager Device for the Intraoperative ... 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 ...

2. clariximaging.com clariximaging.com/

Clarix Imaging - True 3D Specimen Radiography Bringing True 3D Clarity to Specimen Imaging with VSI-360™. INTRAOPERATIVE VOLUMETRIC SPECIMEN IMAGING SYSTEM SPECIALIZED FOR BREAST SURGICAL ONCOLOGY.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8325528/

High-Resolution Full-3D Specimen Imaging for ... A volumetric specimen imager (VSI) was developed to provide full-3D and thin-slice cross-sectional visualization at a 360° view angle.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9119412/

Emerging and future use of intra-surgical volumetric X-ray ... Recent studies have demonstrated that volumetric X-ray imaging improves margin assessment over standard techniques, given the speed of image reconstruction.

5. trialx.com trialx.com/clinical-trials/listings/255948/volumetric-specimen-imager-device-for-the-intraoperative-imaging-of-patients-with-breast-carcinoma-and-breast-ductal-carcinoma-in-situ-the-vivid-study/

Volumetric Specimen Imager Device for the Intraoperative ... 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 ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/K192939.pdf

December 27, 2019 Clarix Imaging Xiao Han, Ph.D. CEO ... The Volumetric Specimen Imager is a Cabinet x-ray system that is used to provide two and three dimensional digital x-ray images of harvested ...