TMEM-MRI: A Pilot Feasibility Study of MRI for Imaging of TMEM in Patients With Operable Breast Cancer
Recruiting
N/AInterventional Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
95 (estimated)
Sponsor
Montefiore Medical Center · Other
Who this trial is looking for
This trial is looking for women with breast cancer to test a new MRI imaging technology. Participants will undergo a specific type of breast MRI to help in managing their condition.
Are You a Good Fit for This Trial?
Rules you outRenal impairmentSickle cell disease
You may be able to join if
I have been diagnosed with invasive breast cancer.
I have a breast mass that is larger than 1 cm.
I am at least 18 years old.
I have not received any preoperative treatment for my breast cancer.
I can undergo an MRI with contrast enhancement.
I am willing to participate in research.
My overall health status allows me to take part.
You may not be able to join if
I have had breast cancer or radiation therapy to the same breast in the past.
I have breast implants.
I have taken any investigational drug in the past 30 days.
I am pregnant or breastfeeding.
I have uncontrolled health issues like serious infections or heart problems.
I have a history of claustrophobia that cannot be treated.
I have a known allergy to gadolinium.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The aim of this study is to assess feasibility of a new imaging technology in the management of breast cancer - Tumor Microenvironment of Metastasis - Magnetic Resonance imaging (TMEM-MRI).
Trial Locations
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Status
Eligibility 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 …
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.
* No preoperative therapy for the current breast cancer has been started (endocrine therapy, chemotherapy, or radiation). Patients can receive preoperative treatment after TMEM-MRI is conducted, if clinically indicated.
* For pilot phase Cohort C:
* Patients with locally advanced breast cancer, anatomic stage II-III, who received neoadjuvant therapy as per standard of care.
* Residual palpable mass \> 1 cm in largest diameter after neoadjuvant therapy.
* Candidate for breast MRI before definitive surgery.
* 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.
* Eastern Cooperative Oncology Group (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. Glomerular Filtration Rate (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.
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