Ultra High Field MRI and MRS Techniques in Diagnosing Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This pilot clinical trial studies ultra-high field magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) techniques in diagnosing breast cancer. New diagnostic procedures may be a more sensitive way to detect breast cancer.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To implement quantitative dynamic contrast-enhanced (DCE)-MRI, diffusion-weighted (DW)-MRI, 31 phosphorus (31P) MRS, magnetization transfer (MT)-MRI, chemical exchange saturation transfer (CEST)-MRI, and high-resolution structural imaging at 7 Tesla in patients for diagnosing breast tumors. OUTLINE: Patients undergo measurement of tumor perfusion and permeability using DCE-MRI, tumor cellularity using DW-MRI, phospholipid metabolism using 31P MRS, macromolecular content using MT-MRI, and cellular protein content using CEST-MRI. Diagnostic performance of one, or a combination, of these metrics will be investigated in the context of breast cancer.

Official Title
-----------------
Ultra-High Field (7 Tesla) MRI/MRS Evaluation of Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Procedure: high field strength magnetic resonance imaging
* Procedure: magnetic resonance spectroscopic imaging
* Procedure: chemical exchange saturation transfer magnetic resonance imaging
* Procedure: diffusion-weighted magnetic resonance imaging
* Procedure: dynamic contrast-enhanced magnetic resonance imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have signed an approved consent form Must be at least 18 years old Subjects must have undergone x-ray mammography and/or ultrasonography Subjects must have undergone standard clinical (1.5 Tesla) MRI as part of their standard-of-care diagnostic workup: To evaluate the extent of disease for a previously diagnosed cancer, or To evaluate a clinically suspected lesion that was occult on mammography and/or ultrasonography, or Because the patient is considered high-risk (according to National Comprehensive Cancer Network [NCCN] criteria) Subjects must be classified Breast Imaging-Reporting and Data System (BI-RADS) 4 or 5 Subjects must be scheduled for diagnostic biopsy to evaluate a lesion that measures >10 mm in the greatest dimension. Exclusion Criteria: Subjects who have distant metastases Subjects who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, aneurysm clip, etc), because such devices may be displaced or malfunction Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced by the magnetic field of the MRI scanner Subjects who may have shrapnel imbedded in their bodies (such as from war wounds), metal workers, and machinists (potential for metallic fragments in or near the eyes) Subjects with a history of renal disease (including renal cancer), diabetes, or human immunodeficiency virus (HIV) Creatinine >= 1.5 times upper limit of normal Estimated glomerular filtration rate < 30 mL/min Subjects who are pregnant or breast-feeding; the MRI Procedure Screening Form will be used to identify and exclude subjects who are pregnant or breastfeeding; a urine pregnancy test/or serum human chorionic gonadotropin (HCG) will also be performed for pre-menopausal women who are not using contraceptives Subjects who have exhibited past allergic or other adverse reactions in response to intravenous injection of Magnevist (gadopentetate dimeglumine) or other gadolinium-containing contrast agents Subjects who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the magnet bore Subjects incapable of giving informed written consent, for the following reasons: Inability to adhere to the experimental protocols for any reason Inability to communicate with the research team Limited ability to give informed consent due to mental disability, altered mental status, confusion, or psychiatric disorders Prisoners or other individuals deemed to be susceptible to coercion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (7T ultra high-field MRI/MRS)<br>Patients undergo measurement of tumor perfusion and permeability using DCE-MRI, tumor cellularity using DW-MRI, phospholipid metabolism using 31P MRS, macromolecular content using MT-MRI, and cellular protein content using CEST-MRI. All of these procedures are integrated into a single MRI exam lasting under 60 min. | Procedure: high field strength magnetic resonance imaging<br>* Undergo 7T MRI<br>* Other names: high field strength MRI;Procedure: magnetic resonance spectroscopic imaging<br>* Undergo 31P MRS<br>* Other names: Proton Magnetic Resonance Spectroscopic Imaging;Procedure: chemical exchange saturation transfer magnetic resonance imaging<br>* Undergo CEST-MRI<br>* Other names: CEST MRI;Procedure: diffusion-weighted magnetic resonance imaging<br>* Undergo DW-MRI<br>* Other names: diffusion-weighted MRI;Procedure: dynamic contrast-enhanced magnetic resonance imaging<br>* Undergo DCE-MRI<br>* Other names: DCE-MRI;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity | Ninety-percent simultaneous confidence rectangles for sensitivity and specificity will be constructed at the 25th, 50th (median), and 75th percentiles of the model predicted probability of disease. | At time of imaging procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological disease status | A generalized linear mixed models analysis of variance with a logit link will be used to predict pathological disease status from MRI and MRS parameters. | At time of imaging procedure |