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

NYU Langone Health

Status: Terminated

Conditions: Breast Cancer; Triple Negative Breast Cancer

Treatments: Diagnostic Test: Sodium (Na) Magnetic Resonance Imaging (MRI); Diagnostic Test: Dynamic Contrast- Enhanced (DCE) MRI

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03750240

17-00269

Details and patient eligibility

About

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).

Enrollment: 2 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

Triple Negative Breast Cancer Patients

Experimental group

Description:

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

Treatment:

Diagnostic Test: Dynamic Contrast- Enhanced (DCE) MRI

Diagnostic Test: Sodium (Na) Magnetic Resonance Imaging (MRI)