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

Primary Purpose

Breast Cancer, Triple Negative Breast Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sodium (Na) Magnetic Resonance Imaging (MRI)
Dynamic Contrast- Enhanced (DCE) MRI
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Triple Negative Breast Cancer Patients

Arm Description

scanned 4 times to assess breast cancer response to NACT with the proposed method.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 20, 2018
Last Updated
August 1, 2022
Sponsor
NYU Langone Health
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03750240
Brief Title
Metabolic Sodium MRI to Assess Early Response of Breast Cancer to Neoadjuvant Chemotherapy
Official Title
Metabolic Sodium MRI to Assess Early Response of Breast Cancer to Neoadjuvant Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
technical difficulties for scans on the research MRI system
Study Start Date
July 25, 2017 (Actual)
Primary Completion Date
June 24, 2021 (Actual)
Study Completion Date
June 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institutes of Health (NIH)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Triple Negative Breast Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Triple Negative Breast Cancer Patients
Arm Type
Experimental
Arm Description
scanned 4 times to assess breast cancer response to NACT with the proposed method.
Intervention Type
Diagnostic Test
Intervention Name(s)
Sodium (Na) Magnetic Resonance Imaging (MRI)
Intervention Description
Two Na data will be acquired: FLORET without Inversion Recovery (IR), and FLORET with IR
Intervention Type
Diagnostic Test
Intervention Name(s)
Dynamic Contrast- Enhanced (DCE) MRI
Intervention Description
DCE MRI will be acquired subsequent to Na MRI to prevent influence of the contrast agent on 23 Na data
Primary Outcome Measure Information:
Title
Change in Tumor Size
Description
Dynamic contrast-enhanced MRI will be used to measure tumor size before and after treatment.
Time Frame
Baseline, 2 Years
Secondary Outcome Measure Information:
Title
Total Sodium Concentration (TSC)
Description
TSC was directly measured from 23Na images using a phantom calibration
Time Frame
Baseline
Title
Intracellular Sodium Concentration (CIC)
Description
CIC is derived from this equation: TSC = ECV · CEC + ICV · CIC + (1 -WF) · Cfat
Time Frame
Baseline

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume Madelin, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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