NCT03750240

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2021

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 24, 2022

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

3.9 years

First QC Date

November 20, 2018

Results QC Date

August 1, 2022

Last Update Submit

August 1, 2022

Conditions

Breast CancerTriple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Change in Tumor Size

    Dynamic contrast-enhanced MRI will be used to measure tumor size before and after treatment.

    Baseline, 2 Years

Secondary Outcomes (2)

  • Total Sodium Concentration (TSC)

    Baseline

  • Intracellular Sodium Concentration (CIC)

    Baseline

Study Arms (1)

Triple Negative Breast Cancer Patients

EXPERIMENTAL

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

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

Interventions

Sodium (Na) Magnetic Resonance Imaging (MRI)DIAGNOSTIC_TEST

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

Triple Negative Breast Cancer Patients
Dynamic Contrast- Enhanced (DCE) MRIDIAGNOSTIC_TEST

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

Triple Negative Breast Cancer Patients

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with no sign of breast cancer as controls
  • Non-pregnant and non-lactating
  • Ability to understand and willingness to sign a written consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsTriple Negative Breast Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Results Point of Contact

Title
Guillaume Madelin, PhD
Organization
NYU Langone Health
guillaume.madelin@nyulangone.org
(212) 263-3343

Study Officials

  • Guillaume Madelin, PhD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2018

First Posted

November 21, 2018

Study Start

July 25, 2017

Primary Completion

June 24, 2021

Study Completion

June 24, 2021

Last Updated

August 24, 2022

Results First Posted

August 24, 2022

Record last verified: 2022-08

Locations

US(1)