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Intraoperative 3D Imaging for Breast Cancer

Phase 2
Recruiting
Led By Swati A Kulkarni, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have histologically confirmed invasive breast cancer, ductal carcinoma in situ (DCIS), or invasive breast cancer with a DCIS component
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 months after breast conservation surgery
Awards & highlights

Study Summary

This trial is assessing if using a 3D imaging device can help surgeons remove all positive margins while in the OR for breast cancer patients.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves diagnostic procedures rather than drugs, traditional side effects aren't expected. However, there may be risks associated with additional surgical time or potential complications from using the new imaging technology.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a type of breast cancer.
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I have breast cancer and will have surgery to remove part of my breast.
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I have had chemotherapy before surgery for breast cancer.
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I have another cancer, but it won't affect this trial's treatment.
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I have cancer in both breasts or in multiple areas of one breast.
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I am planning to have breast-saving surgery with a device to guide the surgery for my breast cancer or DCIS.
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I am a woman aged 18 or older.
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My breast cancer was detected using a mammogram, ultrasound, or MRI.
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My breast cancer can't be seen on a mammogram but is visible on an MRI or ultrasound.
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I can understand and agree to the study's terms on my own or through a legal representative.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 months after breast conservation surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 months after breast conservation surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Positive margins
Secondary outcome measures
Length of time
Sensitivity and specificity
Body tissue
Other outcome measures
Reoperation rate
Retrospective analysis per institutional practice
Retrospective analysis per published guidelines

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (Volumetric Specimen Imager Device)Experimental Treatment2 Interventions
Patients undergo breast conservation surgery (lumpectomy or partial mastectomy) per standard care, and VSI intraoperative imaging is captured on the day of surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumpectomy
2008
N/A
~670

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,275 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,343 Patients Enrolled for Breast Cancer
Northwestern UniversityLead Sponsor
1,579 Previous Clinical Trials
916,665 Total Patients Enrolled
39 Trials studying Breast Cancer
12,475 Patients Enrolled for Breast Cancer
Swati A Kulkarni, MDPrincipal InvestigatorNorthwestern University

Media Library

Intraoperative Imaging Clinical Trial Eligibility Overview. Trial Name: NCT05545150 — Phase 2
Breast Cancer Research Study Groups: Diagnostic (Volumetric Specimen Imager Device)
Breast Cancer Clinical Trial 2023: Intraoperative Imaging Highlights & Side Effects. Trial Name: NCT05545150 — Phase 2
Intraoperative Imaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT05545150 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have joined this research endeavor?

"Affirmative, according to clinicaltrials.gov's records this trial launched on November 28th 2022 and is actively recruiting eligible candidates. To date, 120 participants are required for the single-site study."

Answered by AI

Has the FDA endorsed Intraoperative Imaging for public use?

"While the efficacy of intraoperative imaging is yet to be determined, our team at Power still ranked its safety a 2 due to preliminary data indicating that it poses no risk."

Answered by AI

Does this study still have open enrollments?

"According to the information available through clinicaltrials.gov, this research project is presently recruiting participants; it was initially posted on November 28th 2022 and has been refreshed as of that same date."

Answered by AI
~19 spots leftby Jul 2024