MedTrace Logo

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

NCT03750240 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2022-08-24

Study results available
· View outcomes & findings →

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

Interventions

DIAGNOSTIC_TEST

Sodium (Na) Magnetic Resonance Imaging (MRI)

Two Na data will be acquired: 1. FLORET without Inversion Recovery (IR), and 2. FLORET with IR

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

Sponsors & Collaborators

Principal Investigators

  • Guillaume Madelin, PhD · NYU Langone Health

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-25
Primary Completion
2021-06-24
Completion
2021-06-24
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03750240 on ClinicalTrials.gov