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Intraoperative 3D Imaging for Breast Cancer

Cleveland, OH

Phase 2

Waitlist Available

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

Must not have

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

Patients undergoing re-excision for invasive breast cancer or DCIS are not eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 months after breast conservation surgery

Awards & highlights

No Placebo-Only Group

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.

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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 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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I can understand and agree to the study's terms on my own or through a legal representative.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 months after breast conservation surgery

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Positive margins

Secondary study objectives

Length of time

Sensitivity and specificity

Body tissue

Other study objectives

Reoperation rate

Retrospective analysis per institutional practice

Retrospective analysis per published guidelines

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2017

Completed Phase 2

~740

0 / 9Eligibility criteria met