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

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 Overview

• Status: Terminated
• Conditions: Breast Cancer; Triple Negative Breast Cancer
• Intervention / Treatment: Diagnostic test: Sodium (Na) Magnetic Resonance Imaging (MRI); Diagnostic test: Dynamic Contrast- Enhanced (DCE) MRI

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Guillaume Madelin, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2017
• Primary Completion (Actual): June 24, 2021
• Study Completion (Actual): June 24, 2021

Study Registration Dates

• First Submitted: November 20, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (Actual): November 21, 2018

Study Record Updates

• Last Update Posted (Actual): August 24, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: 17-00269

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No