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

NYU Langone Health2 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Breast Cancer Triple Negative Breast Cancer

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Tumor Size

Dynamic contrast-enhanced MRI will be used to measure tumor size before and after treatment.

Time frame: Baseline, 2 Years

Secondary Outcomes

Total Sodium Concentration (TSC)

TSC was directly measured from 23Na images using a phantom calibration

Time frame: Baseline

Intracellular Sodium Concentration (CIC)

CIC is derived from this equation: TSC = ECV · CEC + ICV · CIC + (1 -WF) · Cfat