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Pre-Surgical MRI + Mammography for Breast Cancer
Study Summary
This trial is testing whether adding an MRI to the standard mammogram improves accuracy in diagnosing breast tumors before surgery.
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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- I have had breast cancer or DCIS in the same breast before.I am a candidate for breast-saving surgery based on exams and imaging.I am scheduled for chemotherapy or targeted radiation before breast surgery.I have cancer in both of my breasts.I have not had chemotherapy for cancer in the last 6 months.I am male.My cancer is ER/PR negative and HER2 positive according to specific guidelines.I am a woman who cannot have breast-conserving therapy based on imaging results.I am scheduled for several lumpectomies due to cancer in multiple locations.My diagnosis was confirmed through surgery.I have been treated with hormonal therapy, tamoxifen, or aromatase inhibitors.I had a breast MRI within the last year.I have harmful changes in my BRCA genes.You have a history of severe claustrophobia that cannot be treated.You have metal objects or medical devices inside your body.I have a history of sickle cell disease.I cannot receive IV contrast due to health reasons.You have had a bad reaction to gadolinium or severe allergic reactions to certain things.Showing signs of kidney failure.I weigh less than the MRI table's maximum limit.My breast cancer is in the early stages (I or II) and was confirmed by a needle biopsy.I can have an MRI and use the contrast dye gadolinium.My breast cancer is not driven by estrogen, progesterone, or HER2.I am 18 years old or older.
- Group 1: Arm 1 (control)
- Group 2: Arm 2 (experimental)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Has the federal government given its stamp of approval to Breast surgery?
"Breast surgery has received a 3 for safety. This is due to the fact that it is a phase 3 trial, so there is both some efficacy data as well as multiple rounds of safety data."
Are there any Canadian sites conducting this research?
"Out of the total 200 sites, 100 are currently recruiting patients. The locations nearest you that are participating in the trial are Neenah, Morgantown and Greer. Reducing travel is important, so please select the location that is most convenient."
Are there any open slots for patients in this research project?
"The information available on clinicaltrials.gov suggests that this study is not actively recruiting patients at this moment. This trial was originally posted on February 1st, 2014 and was last edited on August 1st, 2022. There are 2424 other trials that are currently looking for participants."
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