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

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TMEM-MRI
FNA
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring TMEM;, Magnetic resonance imaging (MRI);, breast cancer.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Montefiore Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Pre-biopsy patients

Post-biopsy patients

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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

Full Information

First Posted
September 28, 2018
Last Updated
July 13, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03694756
Brief Title
TMEM-MRI: A Pilot Feasibility Study of MRI for Imaging of TMEM in Patients With Operable Breast Cancer
Acronym
TMEM-MRI
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2018 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
TMEM;, Magnetic resonance imaging (MRI);, breast cancer.

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be enrolled in 2 cohorts (A and B), based on breast biopsy status.
Masking
None (Open Label)
Masking Description
no need for masking, all patients will undergo TMEM-MRI
Allocation
Non-Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre-biopsy patients
Arm Type
Other
Arm Description
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.
Arm Title
Post-biopsy patients
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
TMEM-MRI
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
FNA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tumor permeability assessed by TMEM-MRI
Description
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.
Time Frame
It will take you about 24 months to complete this research study outcome.
Secondary Outcome Measure Information:
Title
TMEM density in breast cancer patients.
Description
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
Time Frame
It will take you about 24 months to complete this research study outcome.
Title
MenaCalc
Description
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
Time Frame
It will take you about 24 months to complete this research study outcome.
Title
MenaInv
Description
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
Time Frame
It will take you about 24 months to complete this research study outcome.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jesus Anampa, MD,MS
Phone
7184058505
Email
janampa@montefiore.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesus Anampa, MD,MS
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesus D Anampa, MD,MS
Phone
718-405-8505
Email
janampa@montefiore.org
First Name & Middle Initial & Last Name & Degree
Karen Fehn, RN
Phone
7184058505
Email
kfehn@montefiore.org
First Name & Middle Initial & Last Name & Degree
Jesus Anampa, MD
First Name & Middle Initial & Last Name & Degree
Joseph Sparano, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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