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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03750240
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : December 18, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
NYU Langone Health

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).


Condition or disease Intervention/treatment Phase
Breast Cancer Triple Negative Breast Cancer Diagnostic Test: Sodium (Na) Magnetic Resonance Imaging (MRI) Diagnostic Test: Dynamic Contrast- Enhanced (DCE) MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Metabolic Sodium MRI to Assess Early Response of Breast Cancer to Neoadjuvant Chemotherapy
Actual Study Start Date : July 25, 2017
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 12 Triple Negative Breast Cancer Patients
scanned 4 times to assess breast cancer response to NACT with the proposed method.
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




Primary Outcome Measures :
  1. Change in tumor measured by paired sample t tests [ Time Frame: 2 Years ]
    will assess the change in each measure in tumor and healthy tissue from pre-to each post-onset time point and compare tumor to healthy tissue in terms of these changes. Dynamic contrast-enhanced MRI will be used to measure tumor size before and after treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03750240


Contacts
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Contact: Terlika Sood 212 263 3343 terlika.sood@nyumc.org

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Terlinka Sood    212-263-3343    terlika.sood@nyumc.org   
Principal Investigator: Guillaume Sood, MD         
Sponsors and Collaborators
NYU Langone Health
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Guillaume Madelin, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03750240    
Other Study ID Numbers: 17-00269
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases