Breast Cancer Clinical Trial
— TMEM-MRIOfficial title:
TMEM-MRI: A Pilot Feasibility Study of Magnetic Resonance Imaging for Imaging of TMEM (Tumor Microenvironment of Metastasis) in Patients With Operable Breast Cancer
The aim of this study is to assess feasibility of a new imaging technology in the management of breast cancer (TMEM-MRI)
Status | Recruiting |
Enrollment | 75 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tumor permeability assessed by TMEM-MRI | Tumor permeability will be assessed by TMEM-MRI, and is defined as a number of Uth units (the number of tumor voxels with permeability density above threshold divided by the number of all tumor voxels) that will be obtained from the permeability map and TMEM-MRI algorithm. | It will take you about 24 months to complete this research study outcome. | |
Secondary | TMEM density in breast cancer patients. | TMEM density is defined as the number of TMEM units visualized by triple immunohistochemistry in 10 high power fields (40X). TMEM density will be measured with a fully automated and scalable clinical assay for identification and enumeration of TMEM utilizing digital pathology methods coupled with image analysis | It will take you about 24 months to complete this research study outcome. | |
Secondary | MenaCalc | MenaCalc is calculated by subtracting the Z-score value of Mena11a from the Z-score value of pan-Mena, obtained by quantitative immunohistochemistry in formalin-fixed paraffin-embedded breast tumor specimens. MenaCalc can also be measured by qRT-PCR in cancer cells obtained by FNA | It will take you about 24 months to complete this research study outcome. | |
Secondary | MenaInv | MenaInv is calculated as pixel intensity obtained by quantitative immunofluorescence per area of formalin-fixed paraffin-embedded tumor tissue. MenaINV can also be measured by qRT-PCR in cancer cells obtained by FNA | It will take you about 24 months to complete this research study outcome. |
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