TMEM-MRI: A Pilot Feasibility Study of MRI for Imaging of TMEM in Patients With Operable Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/22/2018
Start Date:December 12, 2018
End Date:November 1, 2021
Contact:Jesus Anampa, MD,MS
Email:janampa@montefiore.org
Phone:7184058505

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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)

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.

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.
We found this trial at
1
site
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Jesus Anampa, MD
Phone: 718-405-8505
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
?
mi
from
Bronx, NY
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