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Intraoperative 3D Imaging for Breast Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My lumpectomy specimen is expected to be smaller than 9x9x7 cm.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.I have another cancer, but it won't affect this trial's treatment.I have cancer in both breasts or in multiple areas of one breast.I am planning to have breast-saving surgery with a device to guide the surgery for my breast cancer or DCIS.I am a woman aged 18 or older.My breast cancer was detected using a mammogram, ultrasound, or MRI.I am not having a re-excision for breast cancer.My breast cancer can't be seen on a mammogram but is visible on an MRI or ultrasound.I can understand and agree to the study's terms on my own or through a legal representative.
- Group 1: Diagnostic (Volumetric Specimen Imager Device)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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