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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03750240
• Other study ID #: 17-00269
• Status: Terminated
• Phase: N/A
• Start date: July 25, 2017
• Est. completion date: June 24, 2021

Study information

• Verified date: August 2022
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 24, 2021
• Est. primary completion date: June 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Diagnostic Test:
• Sodium (Na) Magnetic Resonance Imaging (MRI)
Two Na data will be acquired: FLORET without Inversion Recovery (IR), and FLORET with IR
• 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

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Tumor Size	Dynamic contrast-enhanced MRI will be used to measure tumor size before and after treatment.	Baseline, 2 Years
Secondary	Total Sodium Concentration (TSC)	TSC was directly measured from 23Na images using a phantom calibration	Baseline
Secondary	Intracellular Sodium Concentration (CIC)	CIC is derived from this equation: TSC = ECV · CEC + ICV · CIC + (1 -WF) · Cfat	Baseline