Neuroepithelial CystNCT04758104
Assessment of the Efficacy of Stereotactic Intracavitary Instillation of 90Yttrium Colloid
A study testing Yttrium90 in people with Neuroepithelial Cyst, run by David Clarke at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Neuroepithelial Cyst
- What is being tested?
- Yttrium90
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- 23 Mar 2021to 24 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cystic tumor
- Required treatment
- Adult over 17 years of age
- Willingness to provide informed consent
Who cannot join
- Solid tumor
- Treatment not required
- Child under 17 years of age
- Not willing to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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).
- Conditions
- Neuroepithelial Cyst
- Being tested
- Yttrium90
- Medical subject headings
- Colloid cysts of third ventricle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yttrium90Radiation
Intracystic implantation of 90yttrium colloid
| Study group | Role | What they receive |
|---|---|---|
| Yttrium90 | Experimental | Intracystic application of yttrium90 Receives: Radiation: Yttrium90 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 Month
Secondary outcomes (1)
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.
Measured: 1 -4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start23 Mar 2021
- Primary completion24 Jan 2022
- Study completion24 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroepithelial CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Clarke
- Sponsor type
- University, hospital or other
- Collaborators
- Nova Scotia Health Authority
- Responsible party
- Sponsor-investigator, David Clarke, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758104
- Sponsor's protocol ID
- 1026510
- Status last verified
- Jan 2022
- First submitted
- 5 Feb 2021
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04758104
- Acronym / sponsor ID
- 1026510
- Conditions
- Neuroepithelial Cyst
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- David ClarkeUniversity, hospital or other
- Collaborators
- Nova Scotia Health Authority
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 24 Jan 2022 (actual)
- Study completion
- 24 Jan 2022 (actual)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Yttrium90 | Experimental | Radiation: Yttrium90Intracystic application of yttrium90 |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Cystic tumor
- Required treatment
- Adult over 17 years of age
- Willingness to provide informed consent
Key exclusion criteria (4 listed)
- Solid tumor
- Treatment not required
- Child under 17 years of age
- Not willing to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yttrium90Intracystic implantation of 90yttrium colloid | Radiation | Yttrium90 |
Primary outcome
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.
1 secondary outcome
PET-CT scan will be used to visualize the yttrium within the cyst.
Time frame: 1 -4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yttrium90 in people with Neuroepithelial Cyst, run by David Clarke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstration of intracavitary application of 90Yttrium colloid into a cystic tumor in the brain. (time frame: 1 MONTH). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.