Radiomic Markers for Breast Cancer Metastasis and Treatment Response Using MRI

Study Overview
=================
Brief Summary
-----------------
The primary aim of the study is to identify radiomic features as biomarkers of metastatic progression following primary therapy.

Detailed Description
-----------------
The study aims to evaluate radiomic markers in breast tumors to evaluate metastatic risk based on radiomic features following primary therapy. The investigators aim to analyze images at various time intervals before, during and after primary treatments using two advanced imaging techniques (DCE-MRI & DWI-MRI).

Official Title
-----------------
Radiomic Markers for Breast Cancer Metastasis Using Dynamic Contrast Enhanced MRI and Diffusion-Weighted MRI

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must give appropriate written informed consent prior to participation in the study; Subjects must be able and willing to comply with the safety procedures during the scanning period; Subjects must be men and women age 18+ Biopsy-confirmed diagnosis of invasive breast cancer; (ER+/-, PR+/-, HER2+/-). Stage I-III disease according to the AJCC v7 criteria. Patients with sufficient renal function (creatinine clearance, i.e., >=30 mL/min/1.73 m2). Primary treatments can include neoadjuvant chemotherapy or surgery Exclusion Criteria: 1. Subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g. Silicone/saline implants) involving either breast, exclusive of the lesion at issue. 2. Subjects with any dermatologic abnormalities (including tattoos, open sores, or breached skin) involving either breast 3. Subjects with a current or past medical history of connective tissue disease 4. Subjects who are pregnant or lactating 5. Subjects with an implanted electronic device such as a cardiac pacemaker, defibrillator, or neurological stimulator 6. Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study, such as significant anxiety, history of musculoskeletal disease which may predispose them to discomfort during the imaging/scanning period. 7. Allergies to any contrast agent administered to this study.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic complete response (pCR) | Evaluating the degree of absence of residual cancer cells | Up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to distant breast cancer recurrence (months) | Evaluating the time until a recurrence event has occurred in the breast. | Up to 60 months | 
| Time to distant metastasis | Evaluating onset of distant metastasis | Up to 60 months | 
| Time to death | Evaluating time to cancer-related death | Up to 60 months |