Bronx, New York 10461


Purpose:

The aim of this study is to assess feasibility of a new imaging technology in the management of breast cancer (TMEM-MRI)


Study summary:

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.


Criteria:

Inclusion Criteria - For pre-pilot phase (MRI sequence development): o 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: o 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.


NCT ID:

NCT03694756


Primary Contact:

Principal Investigator
Jesus Anampa, MD,MS
Montefiore Medical Center

Jesus Anampa, MD,MS
Phone: 7184058505
Email: janampa@montefiore.org


Backup Contact:

N/A


Location Contact:

Bronx, New York 10461
United States

Jesus D Anampa, MD,MS
Phone: 718-405-8505
Email: janampa@montefiore.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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