Breast Cancer Clinical Trial

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

Summary

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

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Full 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.

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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 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.

Study is for people with:

Breast Cancer

Estimated Enrollment:

41

Study ID:

NCT03694756

Recruitment Status:

Recruiting

Sponsor:

Montefiore Medical Center

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There is 1 Location for this study

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Montefiore Medical Center
Bronx New York, 10461, United States More Info
Jesus D Anampa, MD,MS
Contact
718-405-8505
[email protected]
Karen Fehn, RN
Contact
7184058505
[email protected]
Jesus Anampa, MD
Principal Investigator
Joseph Sparano, MD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

41

Study ID:

NCT03694756

Recruitment Status:

Recruiting

Sponsor:


Montefiore Medical Center

How clear is this clinincal trial information?

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