Ignite Creation Date:
2024-05-06 @ 12:25 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03750240
Status:
TERMINATED
Last Update Posted:
2022-08-24
First Post:
2018-11-20
Brief Title:
Metabolic Sodium MRI to Assess Early Response of Breast Cancer to Neoadjuvant Chemotherapy
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Metabolic Sodium MRI to Assess Early Response of Breast Cancer to Neoadjuvant Chemotherapy
Status:
TERMINATED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
technical difficulties for scans on the research MRI system
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 1H23Na 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
This study will scan 12 patients using 1H23Na 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None