Ignite Creation Date:
2024-05-06 @ 4:01 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04833335
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2021-03-19
Brief Title:
ASL in Brain Metastasis MRI Following Gamma Knife Treatment
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
ASL in Diagnostics of Tumor Progression Versus Radionecrosis in Brain Metastasis Following Gamma Knife Treatment
Status:
RECRUITING
Status Verified Date:
2024-06
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:
GK-ASL
Brief Summary:
Arterial spin labeling ASL is a non-invasive MRI technique that could help the radiologists to distinguish brain metastasis progression versus radionecrosis following gamma-knife treatment
The primary target of the study is to establish the diagnostic performances specificity sensitivity of quantitative measures of ASL in brain metastases suspected of progressionradionecrosis after GK treatment
The primary target of the study is to establish the diagnostic performances specificity sensitivity of quantitative measures of ASL in brain metastases suspected of progressionradionecrosis after GK treatment
Detailed Description:
The metastasis progression versus radionecrosis following GK treatment can sometimes be difficult to distinguish 60 patients will be included in this prospective monocentric study 3 MRI baseline 1month and 6 month follow-ups will be performed Two neuroradiologists will blindly analyse the MRIs comparing ASL sensibility and specificity to the standard morphological evaluation and T2 perfusion
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