Overview
The aim of this study is to assess feasibility of a new imaging technology in the management of breast cancer (TMEM-MRI)
Description
The goal of this study is to assess the feasibility of a new imaging technology in the management of breast cancer. Tumor Microenvironment of Metastasis - Magnetic Resonance imaging (TMEM-MRI) has the ability to detect tumor areas with more leakiness (perfusion), where cancer cell enter blood vessels to travel to other sites. This novel TMEM-MRI has potential to be used in clinical practice to identify tumors with high leakiness that might have higher chances to recur after breast cancer treatment. In addition, TMEM-MRI can potentially be used to assess response to preoperative treatments (chemotherapy, hormonal therapy) over time.
Eligibility
Inclusion Criteria
- For pre-pilot phase (MRI sequence development):
- Patients with a breast mass, with biopsy-proven histology of invasive breast carcinoma (any histologic type and ER,PR,HER2 status)
- For pilot phase cohort A:
- Patients with a breast mass considered highly suspicious for invasive carcinoma by the radiologist (BIRADS 5).
- For pilot phase cohort B:
- Patients with a breast mass found to be invasive ductal carcinoma on core biopsy.
- The tumor should be considered operable by the breast surgeon.
- No preoperative therapy for the current breast cancer is planned (endocrine therapy, chemotherapy, or radiation).
- Tumor size/breast mass should be > 1 cm in largest diameter (radiologically).
- Multifocal disease is allowed, as long as patients meet all eligibility criteria.
- Age ≥ 18 years.
- ECOG performance status 0-1.
- Willingness to undergo a "research breast MRI".
- Patient must be able to undergo MRI with gadolinium enhancement.
- No history of untreatable claustrophobia.
- No presence of non MRI compatible metallic objects or metallic objects that, in the opinion of a radiologist, would make MRI a contraindication.
- No history of sickle cell disease.
- No contraindication to intravenous contrast administration.
- No known allergy-like reaction to gadolinium
- No known or suspected renal impairment. GFR should be greater than 30 mL/min/1.73 m2.
- Weight less than or equal to the MRI table limit.
- Ability to understand and willingness to sign a written informed consent.
Exclusion Criteria
- Patients may not have had breast cancer or radiation therapy to the ipsilateral breast in the past.
- No breast prosthetic implants (silicone or saline) are allowed.
- Use of any investigational agent within 30 days of starting study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study.
- Patients must be non-pregnant and non-lactating. Patients must have a negative pregnancy test (urine or serum) within 7 days of registration date.