Initial diagnosis. Women with mammographic or palpable abnormality who will be undergoing a breast biopsy, either an excisional biopsy, needle localization and excision, core needle biopsy or fine needle aspiration biopsy. The purpose of this study is to determine whether MRI can differentiate benign from malignant lesions. See description of the Consortium study for more information.
Suspected or newly diagnosed breast cancer. Patients with suspected or newly diagnosed breast cancer who will be undergoing further surgery are eligible for this study. Ideally, we would like to image women prior to excisional biopsy. However, as many women come to Penn for a second opinion following initial excisional biopsy, we will image women prior to reexcisional biopsy. We, however, will not image women who have already undergone definitive surgery out of concern that MRI findings could result in an unnecessary additional procedure. It is very important in this group of women to explain the potential for MRI to identify additional suspicious lesions in the breast. The identification of additional lesions can result in the need for MRI guided localization. It is also important that patients understand that the surgery, whether it be initial excision, reexcision or mastectomy, must be performed at the Hospital of the University of Pennsylvania. The reason for this is that if we identify an additional suspicious area on MRI this lesion would need to be localized prior to surgery with an MRI-guided localization procedure.
Axillary node malignancy unknown primary. Women with axillary lymph node biopsy showing carcinoma are eligible for MRI to identify a potential breast primary. We have demonstrated very promising results in this population.
Locally advanced breast cancer. Women with newly diagnosed locally advanced breast cancer can be imaged with MRI prior to initiation of radiation and/or chemotherapy and followed during their treatment to look for changes in the tumor on MRI as compared to mammography and physical examination.
High risk screening. We are beginning to screen women with a high risk of breast cancer, specifically women who will test positive for the BRCA-1 and 2 genes. At this point we are only screening these very high risk women. We are not screening women in general, including women who have already had a breast cancer. The reason for this is that while MRI appears to be very sensitive for the identification of breast cancer, the specificity remains limited: Many benign lesions and sometimes normal breast tissue enhance following MRI contrast administration.
MRI microscopy at 4.0 Telsa. We are performing 150 micron resolution images of (mammographically or clinically detected) suspicious breast lesions in our new 4 T facility. The study includes the suspicious lesion only, the remainder of the breast not being imaged.
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A CONSORTIUM OF 14 CLINICAL SITES HAS BEEN ORGANIZED TO PERFORM A STUDY ON THE PERFORMANCE CHARACTERISTICS OF BREAST MRI IN 2 APPLICATIONS: CHARACTERIZING LESIONS IN PATIENTS WITH SUSPICIOUS MAMMOGRAPHIC OR CLINICAL FINDINGS AND DETERMINING THE EXTENT OF CANCER WITHIN AN AFFECTED BREAST.
ALL SITES WILL UTILIZE A DEDICATED BREAST IMAGING COIL. THE INITIAL IMAGING PROTOCOL CONSISTS OF A T2 WEIGHTED RAPID (FAST OR TURBO) SPIN ECHO SEQUENCE WITH <= 4 MM SLICES AND TR/TE APPROXIMATELY EQUAL TO 4000/90. THIS IS FOLLOWED BY A 3D T1 WEIGHTED SEQUENCE PRIOR TO AND AFTER THE ADMINISTRATION OF 0.1mM/kgGd CHELATE, THE INJECTION WILL BE GIVEN OVER 10 SECONDS THROUGH A 20 OR 22 GAUGE IV CATHETER AND WILL BE FOLLOWED BY A FLUSH OF 20 ml OF SALINE. THE SCAN PROTOCOL WILL CONSIST OF 3d GRADIENT ECHO SEQUENCE WITH TR<=20 TE<= 4.5 AND A FLIP ANGLE OF 45 DEGREES. IMAGING WILL BE PERFORMED ON A 16-18 cm FOV OVER A MINIMUM MATRIX OF 256 X 128 AND 32-128<=3mm SLICES DEPENDING ON THE SIZE OF THE BREAST. THE TOTAL IMAGING TIME FOR THIS SEQUENCE WILL BE LESS THAN 4 MINUTES. FAT SUPPRESSION MUST BE UTILIZED.
SEQUENCE: 3D SPOILED GE
TR (SEC): <= .020
TE (mS): <= 4.5
FLIP: <= 45
PATIENTS WITH FOCAL ABNORMALITIES WILL RETURN FOR A TIME RESOLVED STUDY. THE TIME RESOLVED STUDY WILL CONSIST OF A T1 MEASUREMENT OF THE REGION OF INTEREST FOLLOWED BY COLLECTION OF SEQUENTIAL 2D IMAGES AFTER THE INTRAVENOUS ADMINISTRATION OF GADOLINIUM. THE T1 MEASUREMENT WILL BE EXTRACTED FROM SPOILED GRADIENT ECHO ACQUISITIONS WITH A 90 DEGREE FLIP ANGLE AND A VARIABLE TR. THIS WILL BE PERFORMED ON THE SAME SLICE LOCATIONS AS THE TIME RESOLVED ACQUISITION. TWO DIMENSIONAL T1 WEIGHTED SPOILED GRADIENT ECHO IMAGES WILL THEN BE TAKEN AT 15 SECOND INTERVALS AFTER THE ADMINISTRATION OF GADOLINIUM OVER A TOTAL OF 5 MINUTES AND 15 SECONDS. THE ACQUISITION MATRIX WILL BE 256 X 128 AND THE SLICE THICKNESS WILL BE 4 mm. IN ORDER THAT THE TIME RESOLVED DATA FROM DIFFERENT SITES CAN BE DIRECTLY COMPARED, ALL SITES WILL BE ASKED TO USE THE SAME TIMING PARAMETERS FOR THE TIME COURSE MEASUREMENTS AND T1 MEASUREMENTS:
DYNAMIC SCAN
CONTRAST INJECTION
BREAST MRI PROTOCOL AND PILOT STUDY; HIGH RISK BREAST CANCER SCREENING PILOT STUDY
ENTRANCE CRITERIA
WOMEN OF ALL RACES AND ETHNIC GROUPS OVER 18 YEARS OF AGE WILL BE ELIGIBLE FOR THE STUDY. BASED ON OUR PRELIMINARY RESULTS, WE EXPECT 30 % OF THE PATIENTS RECRUITED INTO THE TRIAL TO BE LESS THAN 50 YEARS OLD. TWENTY-FIVE PERCENT OF THE PATIENTS RECRUITED WILL BE NON WHITE. THUS THESE GROUPS WILL BE ADEQUATELY REPRESENTED. ALL PATIENTS MUST HAVE BEEN REFERRED FOR BREAST BIOPSY FOR ONE OF THE FOLLOWING REASONS:
SUSPICIOUS MAMMOGRAPHIC FINDING OR PALPABLE ABNORMALITY (DEFINED AS ACR CATEGORY 4 AND CATEGORY 5 INTERPRETATIONS) (SEE SECTION 8.2).
SUSPICIOUS CLINICAL OR ULTRASOUND FINDING WITHOUT ASSOCIATED BENIGN MAMMOGRAPHIC FEATURES.
PATIENTS MEETING CRITERIA 1 OR 2 WITH BREAST IMPLANTS ARE ELIGIBLE FOR THIS STUDY.
PATIENT MEETING CRITERIA 1 OR 2 WITH PRIOR BENIGN EXCISIONAL OR CORE BIOPSY (> 6 MONTHS PRIOR) ARE ELIGIBLE. PATIENTS WITH FNA PERFORMED AT ANYTIME ARE ELIGIBLE.
PATIENTS WITH MORE THAN ONE SUSPICIOUS LESION BASED ON MAMMOGRAPHY OR CLINICAL EXAM ARE ELIGIBLE IF AN INDEX IS PRESENT (SEE SECTION 7.2).
PATIENTS THAT MEET CRITERIA 1 OR 2 AND HAVE HAD A CANCER IN THE CONTRALATERAL BREAST ARE ELIGIBLE.
PATIENTS MUST AGREE TO FOLLOWUP AS OUTLINED IN SECTION 14.0.
PATIENTS MUST SIGN A STUDY-SPECIFIC CONSENT FORM PRIOR TO STUDY ENTRY.
EXCLUSION CRITERIA
PATIENTS WITH A CONTRAINDICATION TO MRI EXAMINATION:
BENIGN EXCISIONAL OR CORE BIOPSY OF THE AFFECTED BREAST WITHIN THE LAST 6 MONTHS
HISTORY OF PRIOR BREAST CANCER IN THE STUDY BREAST.
PREGNANT PATIENTS WILL BE EXCLUDED FROM THE STUDY.
AGE < 18 YEARS OLD OR > 80 YEARS OLD.
DECISIONALLY IMPAIRED.
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