Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309810
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2023-06-20
Brief Title:
Stereotactic Radiosurgery SRS in Malignant Spasticity and Hypertonia
Sponsor:
IRCCS Sacro Cuore Don Calabria di Negrar
Organization:
IRCCS Sacro Cuore Don Calabria di Negrar
Study Overview
Official Title:
Stereotactic Radiosurgery SRS in Malignant Spasticity and Hypertonia a Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-03
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:
This is a pilot experimental monocentric study The main objective of the study is to evaluate whether stereotactic radiotherapy is able to reduce symptomatic spasticity from a clinical point of view and therefore induce an improvement in posture and quality of life in patients with malignant spasticity
The study foresees the enrollment of about 10 patients in a period of 24 months The radiotherapy treatment will be delivered in a single session with an image-guided stereotaxic technique and a prescription dose between 45 and 60 Gy subsequently the patients will be followed up for one year
The study foresees the enrollment of about 10 patients in a period of 24 months The radiotherapy treatment will be delivered in a single session with an image-guided stereotaxic technique and a prescription dose between 45 and 60 Gy subsequently the patients will be followed up for one year
Detailed Description:
None
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