Metabolic Sodium MRI to Assess Early Response of Breast Cancer to Neoadjuvant Chemotherapy
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|ClinicalTrials.gov Identifier: NCT03750240|
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : December 18, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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:
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
- 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.
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
|Contact: Terlika Sood||212 263 email@example.com|
|United States, New York|
|NYU Langone Health||Recruiting|
|New York, New York, United States, 10016|
|Contact: Terlinka Sood 212-263-3343 firstname.lastname@example.org|
|Principal Investigator: Guillaume Sood, MD|
|Principal Investigator:||Guillaume Madelin, MD||NYU Langone Health|