Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 3A7, Canada
Completed
NCT Number: NCT04758104
Assessment of the Efficacy of Stereotactic Intracavitary Instillation of 90Yttrium Colloid
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.
Completed
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Notify MeKey information
Age range
17 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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).
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Cystic tumor
- Required treatment
- Adult over 17 years of age
- Willingness to provide informed consent
Exclusion criteria
- Solid tumor
- Treatment not required
- Child under 17 years of age
- Not willing to provide informed consent
Treatment and study plan
Yttrium90
RadiationIntracystic implantation of 90yttrium colloid
Primary outcomes
-
Demonstration of intracavitary application of 90Yttrium colloid into a cystic tumor in the brain.
Time frame: 1 MONTH
90Yttrium colloid will be inserted into the cyst using neurosurgical techniques.
-
Shrinkage of cyst
Time frame: 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 outcomes
-
PET-CT scan will be used to visualize the yttrium within the cyst.
Time frame: 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.
Sponsors and collaborators
Lead sponsor
David Clarke
Other
Collaborators
- Nova Scotia Health Authority
Registry information
Official study 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
Important dates
- Study start
- 2021
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- Feb 17, 2021
- Registry last updated
- Jan 28, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.