Metabolic Sodium MRI to Assess Early Response of Breast Cancer to Neoadjuvant Chemotherapy

Study Overview
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Brief Summary
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Neoadjuvant chemotherapy (NACT) is administered to treat invasive breast cancer before surgery. It offers the opportunity to evaluate tumor response to treatment in aggressive disease, and guide additional therapies for patients with inadequate response, if detected early. Investigators propose to develop a sodium breast MRI technique that will allow to assess the early metabolic response of breast cancer to NACT, occurring before late structural changes can be detected with standard MRI. This study will scan 12 patients using 1H/23Na MRI at 7 T and DCE MRI with triple-negative breast cancer undergoing AC-T therapy (2 months of Adriamycin + Cyclophosphamide, then 3 months of Taxol): at baseline (pre-NACT); after the first AC cycle (2 weeks); after AC treatment (2 months); after complete NACT (5 months, pre-surgery).

Official Title
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Metabolic Sodium MRI to Assess Early Response of Breast Cancer to Neoadjuvant Chemotherapy

Conditions
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Breast Cancer, Triple Negative Breast Cancer

Intervention / Treatment
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* Diagnostic Test: Sodium (Na) Magnetic Resonance Imaging (MRI)
* Diagnostic Test: Dynamic Contrast- Enhanced (DCE) MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with no sign of breast cancer as controls Non-pregnant and non-lactating Ability to understand and willingness to sign a written consent Exclusion Criteria: Contra-indications to MRI (i.e., ferromagnetic prostheses, metallic surgical implants that are not compatible with an MRI machine, claustrophobia etc.) Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient. Pregnant or lactating women, women using hormonal treatment in the 6 months prior to the study. Women with history of breast disease, previous breast surgery, or breast implants. Patients with a currently active second malignancy other than non-melanoma skin cancers. Patients are not considered to have a currently active malignancy if they have completed therapy and are free of disease for 3 years. Psychiatric illness or other conditions and circumstances which could prevent the patient from being compliant with the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triple Negative Breast Cancer Patients<br>scanned 4 times to assess breast cancer response to NACT with the proposed method. | Diagnostic Test: Sodium (Na) Magnetic Resonance Imaging (MRI)<br>* Two Na data will be acquired: FLORET without Inversion Recovery (IR), and FLORET with IR<br>Diagnostic Test: Dynamic Contrast- Enhanced (DCE) MRI<br>* DCE MRI will be acquired subsequent to Na MRI to prevent influence of the contrast agent on 23 Na data<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tumor Size | Dynamic contrast-enhanced MRI will be used to measure tumor size before and after treatment. | Baseline, 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sodium Concentration (TSC) | TSC was directly measured from 23Na images using a phantom calibration | Baseline | 
| Intracellular Sodium Concentration (CIC) | CIC is derived from this equation: TSC = ECV · CEC + ICV · CIC + (1 -WF) · Cfat | Baseline |