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

Not Applicable

Terminated

• Conditions: Breast Cancer; Triple Negative Breast Cancer
• Interventions: Diagnostic Test: Sodium (Na) Magnetic Resonance Imaging (MRI); Diagnostic Test: Dynamic Contrast- Enhanced (DCE) MRI

• Registration Number: NCT03750240
• Lead Sponsor: NYU Langone Health

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-25
• Study First Submitted: 2018-11-20
• Study First Submitted QC: 2018-11-20
• Study First Posted: 2018-11-21
• Primary Completion: 2021-06-24
• Study Completion: 2021-06-24
• Status Verified: 2022-08
• Results First Submitted: 2022-08-01
• Results First Submitted QC: 2022-08-01
• Last Update Submitted: 2022-08-01
• Results First Posted: 2022-08-24
• Last Update Posted: 2022-08-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Triple Negative Breast Cancer Patients	Sodium (Na) Magnetic Resonance Imaging (MRI)	scanned 4 times to assess breast cancer response to NACT with the proposed method.
Triple Negative Breast Cancer Patients	Dynamic Contrast- Enhanced (DCE) MRI	scanned 4 times to assess breast cancer response to NACT with the proposed method.

Primary Outcome Measures

Name	Time	Method
Change in Tumor Size	Baseline, 2 Years	Dynamic contrast-enhanced MRI will be used to measure tumor size before and after treatment.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States