Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2025-12-17 @ 6:06 PM
Study NCT ID:
NCT05868928
Status:
None
Last Update Posted:
2024-05-14 00:00:00
First Post:
2023-04-16 00:00:00
Brief Title:
Imaging Features for the Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis
Sponsor:
Asan Medical Center
Organization:
Asan Medical Center
Study Overview
Official Title:
Imaging Risks for Recurrence After Stereotactic Radiosurgery in Brain Metastasis (IRRAS-BM)
Status:
None
Status Verified Date:
2024-05
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:
None
Brief Summary:
PRIMARY OBJECTIVE:
I. To develop an imaging risk score for recurrence after stereotactic radiosurgery (SRS) in brain metastasis using multiparametric MRI.
II. To validate the imaging risk score in retrospective external validation and prospective internal validation test set.
SECONDARY OBJECTIVE:
I. To predict radiation necrosis using imaging risk score.
OUTLINE:
Participants undergo multi-parametric MRI including 3D pre- and contrast-enhanced T1 weighted image, T2 weighted image, diffusion-weighted image, dynamic susceptibility contrast MRI, and arterial spin labeling image before receiving SRS, and every 3 months after SRS.
I. To develop an imaging risk score for recurrence after stereotactic radiosurgery (SRS) in brain metastasis using multiparametric MRI.
II. To validate the imaging risk score in retrospective external validation and prospective internal validation test set.
SECONDARY OBJECTIVE:
I. To predict radiation necrosis using imaging risk score.
OUTLINE:
Participants undergo multi-parametric MRI including 3D pre- and contrast-enhanced T1 weighted image, T2 weighted image, diffusion-weighted image, dynamic susceptibility contrast MRI, and arterial spin labeling image before receiving SRS, and every 3 months after SRS.
Detailed Description:
PRIMARY OBJECTIVE
I To develop an imaging risk score for recurrence after stereotactic radiosurgery SRS in brain metastasis using multiparametric MRI
II To validate the imaging risk score in retrospective external validation and prospective internal validation test set
SECONDARY OBJECTIVE
I To predict radiation necrosis using imaging risk score
OUTLINE
Participants undergo multi-parametric MRI including 3D pre- and contrast-enhanced T1 weighted image T2 weighted image diffusion-weighted image dynamic susceptibility contrast MRI and arterial spin labeling image before receiving SRS and every 3 months after SRS
I To develop an imaging risk score for recurrence after stereotactic radiosurgery SRS in brain metastasis using multiparametric MRI
II To validate the imaging risk score in retrospective external validation and prospective internal validation test set
SECONDARY OBJECTIVE
I To predict radiation necrosis using imaging risk score
OUTLINE
Participants undergo multi-parametric MRI including 3D pre- and contrast-enhanced T1 weighted image T2 weighted image diffusion-weighted image dynamic susceptibility contrast MRI and arterial spin labeling image before receiving SRS and every 3 months after SRS
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