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

NCT ID: NCT03750240

Last Updated: 2022-08-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-25
• Study Completion Date: 2021-06-24

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).

Conditions

Breast Cancer; Triple Negative Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Triple Negative Breast Cancer Patients

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

Group Type: EXPERIMENTAL

Sodium (Na) Magnetic Resonance Imaging (MRI)

Intervention Type: DIAGNOSTIC_TEST

Two Na data will be acquired:

1. FLORET without Inversion Recovery (IR), and

2. FLORET with IR

Dynamic Contrast- Enhanced (DCE) MRI

Intervention Type: DIAGNOSTIC_TEST

DCE MRI will be acquired subsequent to Na MRI to prevent influence of the contrast agent on 23 Na data

Interventions

Sodium (Na) Magnetic Resonance Imaging (MRI)

Two Na data will be acquired:

1. FLORET without Inversion Recovery (IR), and

2. FLORET with IR

Intervention Type: 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

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guillaume Madelin, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

17-00269

Identifier Type: -

Identifier Source: org_study_id