Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT01898533
Status:
COMPLETED
Last Update Posted:
2018-08-01
First Post:
2013-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility of Blood Oxygenation Level-Dependent Contrast (BOLD) Breast MRI Induced by Breath- Holding
Sponsor:
Duke University
Organization:
Study Overview
Official Title:
A Pilot Study of the Feasibility of Blood Oxygenation Level-Dependent Contrast ( BOLD) Breast MRI Induced by Breath- Holding
Status:
COMPLETED
Status Verified Date:
2018-07
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:
BOLD
Brief Summary:
In this study, investigators intend to measure changes in BOLD contrast in the breast induced by breath-holding for subjects receiving radiation therapy to the breast. This study will provide the preliminary data and experience needed to successfully apply BOLD to quantify changes in oxygenation and blood flow of breast and tumor for a larger cohort of breast radiotherapy patients. The current study has the following objectives:
1. To determine the feasibility of BOLD contrast MRI of the breast, induced by breath-hold.
2. To measure the change in BOLD contrast of the breast and / or chest wall tissue for females undergoing radiotherapy
1. To determine the feasibility of BOLD contrast MRI of the breast, induced by breath-hold.
2. To measure the change in BOLD contrast of the breast and / or chest wall tissue for females undergoing radiotherapy
Detailed Description:
11 subjects were consented to the trial. One subject voluntarily withdrew before any study procedures were performed.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: