Assessment of the Efficacy of Stereotactic Intracavitary Instillation of 90Yttrium Colloid

Not Applicable

Completed

• Conditions: Neuroepithelial Cyst
• Interventions: Radiation: Yttrium90

• Registration Number: NCT04758104
• Lead Sponsor: David Clarke

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 (http://neurosurgery.medicine.dal.ca).

Study Timeline

• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-16
• Study First Posted: 2021-02-17
• Study Start: 2021-03-23
• Status Verified: 2022-01
• Primary Completion: 2022-01-24
• Study Completion: 2022-01-24
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Yttrium90	Yttrium90	Intracystic application of yttrium90

Primary Outcome Measures

Name	Time	Method
Demonstration of intracavitary application of 90Yttrium colloid into a cystic tumor in the brain.	1 MONTH	90Yttrium colloid will be inserted into the cyst using neurosurgical techniques.
Shrinkage of cyst	1 Month	Intracystic application of 90Yttrium colloid will result in the shrinkage of the cyst.To estimate the efficacy of intracavitary application of 90Yttrium colloid for the treatment of an adult with a cystic tumor in the brain by a single neurosurgeon.

Secondary Outcome Measures

Name	Time	Method
PET-CT scan will be used to visualize the yttrium within the cyst.	1 -4 days	We will be evaluating the utility of positron emission tomography - computed tomography (PET-CT) in demonstrating that the distribution of 90yttrium colloid is confined to the cyst.

Trial Locations

Locations (1)

Nova Scotia Health Authority; 🇨🇦 Halifax, Nova Scotia, Canada