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

Neuroepithelial Cyst Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04758104
• Other study ID #: 1026510
• Status: Completed
• Phase: N/A
• Start date: March 23, 2021
• Est. completion date: January 24, 2022

Study information

• Verified date: January 2022
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: January 24, 2022
• Est. primary completion date: January 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion criteria:

1. Cystic tumor

2. Required treatment

3. Adult over 17 years of age

4. Willingness to provide informed consent

Exclusion criteria

1. Solid tumor

2. Treatment not required

3. Child under 17 years of age

4. Not willing to provide informed consent

Related Conditions & MeSH terms

• Neuroepithelial Cyst

Intervention

Radiation:
• Yttrium90
Intracystic implantation of 90yttrium colloid

Locations

Country	Name	City	State
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
David Clarke	Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	PET-CT scan will be used to visualize the yttrium within the cyst.	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.	1 -4 days