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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Jesus Anampa Mesias，Montefiore Medical Center

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

November 1, 2018

Estimated Primary Completion Date

November 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Tumor permeability assessed by TMEM-MRI[ Time Frame: It will take you about 24 months to complete this research study outcome. ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

TMEM density in breast cancer patients.[ Time Frame: It will take you about 24 months to complete this research study outcome. ]
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
MenaCalc[ Time Frame: It will take you about 24 months to complete this research study outcome. ]
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
MenaInv[ Time Frame: It will take you about 24 months to complete this research study outcome. ]
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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

TMEM-MRI: A Pilot Feasibility Study of Magnetic Resonance Imaging for Imaging of TMEM (Tumor Microenvironment of Metastasis) in Patients With Operable Breast Cancer

Brief Summary

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

Detailed 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.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be enrolled in 2 cohorts (A and B), based on breast biopsy status.
Masking: Interventional
Masking Description:no need for masking, all patients will undergo TMEM-MRI
Primary Purpose: Other

Condition ^ICMJE

Intervention ^ICMJE

Device: TMEM-MRI
TMEM MRI INFORMATION: Unilateral breast MRI will be obtained on a 3.0T whole body MRI scanner with a dedicated breast radiofrequency coil. The patient will be scanned in the prone position with an in-dwelling IV catheter for a single dose contrast agent injection.
Procedure: FNA
FNA: The patients who are recruited prior to biopsy (Cohort A) will have had TMEM-MRI performed prior to biopsy. They will then present to radiology for ultrasound-guided core biopsy of the breast mass. FNA will be performed during this procedure. The FNA will be performed after local anesthetic is administered but prior to insertion of the core biopsy needle. FNA will be performed by the radiologist under direct sonographic visualization of the mass. Five passes will be obtained with a 25 gauge needle. The FNA material will be expelled into 1.5 ml Eppendorf tube containing phosphate buffered saline with EDTA.

Study Arms

Other: Pre-biopsy patients
Patients identified by a radiologist at the time of diagnostic evaluation. Once consent is obtained, the TMEM-MRI will be scheduled. After TMEM-MRI, the patient will undergo core biopsy as per usual radiology procedure, with additional FNA at the time of core biopsy (preceding the core biopsy). MenaINV and MenaCalc will be calculated from the FNA material. After the breast biopsy confirms the suspected diagnosis of invasive breast carcinoma, the patient will be referred to breast surgery and a treatment plan devised, as per NCCN/ASCO guidelines. TMEM density, MenaCalc and MenaINV will be also calculated from the specimen obtained at the time of definitive surgery. Uth qTPERM will be correlated with TMEM density, MenaCalc and MenaINV.
Other: Post-biopsy patients
Patients after breast biopsy. Once consent is obtained, patients will undergo TMEM-MRI. The patients will undergo definitive breast surgery and will receive adjuvant treatments as per NCCN/ASCO guidelines. TMEM density, MenaCalc and MenaINV will be evaluated in final surgical specimen. Uth qTPERM will be correlated with TMEM density, MenaCalc and MenaINV.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

November 1, 2021

Estimated Primary Completion Date

November 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Jesus Anampa Mesias，Montefiore Medical Center

Study Sponsor ^ICMJE

Montefiore Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Jesus Anampa, MD,MS Montefiore Medical Center

PRS Account

Montefiore Medical Center

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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