Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400563
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-04-11
Brief Title:
MRg-NIRS Imaging System Breast Cancer Trial
Sponsor:
Keith D Paulsen
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
Evaluation of the Magnetic Resonance-guided MRg Near-infrared Spectroscopy NIRS Imaging System Platform in Breast Cancer Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MRg-NIRS
Brief Summary:
This trial is a study of 20 women with breast cancer to evaluate the addition of MR-guided MRg near-infrared spectroscopy NIRS with and without contrast as part of a program to improve clinical management of women receiving breast magnetic resonance imaging MRI
Detailed Description:
This trial is designed to determine if the MRg-NIRS system will contribute significantly to improved clinical management of women receiving breast magnetic resonance imaging MRI by achieving diagnostic performance comparable to or better than dynamic contrast-enhanced DCE breast MRI alone
The purpose of this clinical trial is to evaluate the addition of MRg-NIRS with and without contrast in 20 women with breast cancer The women enrolled in the trial will be those who have a newly diagnosed breast cancer
The purpose of this clinical trial is to evaluate the addition of MRg-NIRS with and without contrast in 20 women with breast cancer The women enrolled in the trial will be those who have a newly diagnosed breast cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None