Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04758104
Status:
COMPLETED
Last Update Posted:
2022-01-28
First Post:
2021-02-05
Brief Title:
Assessment of the Efficacy of Stereotactic Intracavitary Instillation of 90Yttrium Colloid
Sponsor:
David Clarke
Organization:
Nova Scotia Health Authority
Study Overview
Official Title:
Assessment of the Efficacy of Stereotactic Intracavitary Instillation of 90Yttrium Colloid for Treatment of Cystic Lesions of the Brain Open Label Individual Patient OLIP Study
Status:
COMPLETED
Status Verified Date:
2022-01
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:
Neuroepithelial cysts are rare representing less than 1 of the intracranial cysts Neuroepithelial cysts are benign and mostly asymptomatic These cysts are lined by thin columnar or low cuboidal epithelium The CSF-like contents of the cyst are due to secretion of the epithelial cyst wall Although mostly asymptomatic symptoms can occur when the cyst enlarges the specific symptoms vary according to the size mass effect and location of the lesion Radioactive phosphorus 32P and 90yttrium colloid are isotopes that have been used These are approved in the United States and Europe 32P is not available in Canada We want to use 90yttrium colloid There is evidence in the scientific literature that treatment with 90yttrium colloid injected into the cyst is effective in preventing the cyst from growing effective in causing the cyst to get smaller and in some cases the cyst disappears
Detailed Description:
In brief a single patient has been identified as having a cystic tumor by diagnostic imaging and clinical expertise and based on standards of excellence in clinical care will be offered participation in the study for the intracystic implantation of 90yttrium colloid This patient will be followed closely for 4 weeks following 90yttrium colloid treatment and then receive standard of care httpneurosurgerymedicinedalca
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