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

NCT04758104 | Completed DMC

• 1 other identifier: 1026510
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroepithelial Cyst

Outcome Measures

Primary Outcomes (2)

• Demonstration of intracavitary application of 90Yttrium colloid into a cystic tumor in the brain.

  90Yttrium colloid will be inserted into the cyst using neurosurgical techniques.

  1 MONTH

• Shrinkage of cyst

  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.

  1 Month

Secondary Outcomes (1)

• PET-CT scan will be used to visualize the yttrium within the cyst.

  1 -4 days

Study Arms (1)

Yttrium90

EXPERIMENTAL

Intracystic application of yttrium90

Radiation: Yttrium90

Interventions

Yttrium90 RADIATION

Intracystic implantation of 90yttrium colloid

Yttrium90

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Cystic tumor
• Required treatment
• Adult over 17 years of age
• Willingness to provide informed consent

You may not qualify if:

• Solid tumor
• Treatment not required
• Child under 17 years of age
• Not willing to provide informed consent

Sponsors & Collaborators

• David Clarke: lead
• Nova Scotia Health Authority: collaborator

Study Sites (1)

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 3A7, Canada

Location

MeSH Terms

Conditions

Colloid cysts of third ventricle

Interventions

Yttrium-90

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Neurosurgeon

Model Details: 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.

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 17, 2021
• Study Start: March 23, 2021
• Primary Completion: January 24, 2022
• Study Completion: January 24, 2022
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)