Cystic Tumors of the Sellar/Parasellar RegionPhase 3NCT02081768
90Yttrium Colloid for the Treatment of Cystic Sellar/Parasellar Tumors
A Phase 3 study testing 90yttrium colloid in people with Cystic Tumors of the Sellar/Parasellar Region, run by David Clarke at 1 site in Canada.
Trial summary
There is no consensus in the literature on the best way to treat cystic lesions of the pituitary area. Patients who are symptomatic from these tumours are rare. The cystic form of tumours present special challenges since traditional treatment modalities (surgery and/or external radiation) are often not able to… Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Cystic Tumors of the Sellar/Parasellar Region
- What is being tested?
- 90yttrium colloid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to 31 Oct 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Patients who meet all of the following criteria are eligible for enrollment as study participants:
- Patients 17 years of age or older.
- Cystic sellar, suprasellar, parasellar or intrasellar masses diagnosed by histology, cytology or neuroimaging.
- Tumour measurements and/or tumour volume can be calculated.
- Patients who require surgical intervention as determined by the treating neurosurgeon.
- Being a patient managed in the Halifax Neuropituitary Program surgical clinic.
- Willingness to undergo surgery and give informed surgical consent.
- Willingness to provide informed consent for study participation.
Who cannot join
- Patients who meet any of these criteria are not eligible for enrollment as study participants:
- Neurosurgeon's assessment that surgical procedures hold unacceptable operative risk.
- Having a solid tumour.
- Pregnant or breast feeding at time of surgical consent and/or surgery.
- Hypersensitivity, allergies or contraindication to the used radiopharmaceutical agent (90yttrium colloid).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
David B. Clarke, MDCM, PhD, FRCSC, DABNS, FACS contact
Canada1 site, 1 recruiting
- Recruiting
Halifax Infirmary
Halifax, Nova Scotia, B3H 3A7
David B. Clarke, MDCM, PhD, FRCSC, DABNS, FACS, 902-473-4591, d.clarke@dal.ca
David B. Clarke, 902-473-4591
About this study
Official title: Assessment of the Efficacy of Stereotactic Intracavitary Instillation of 90yttrium Colloid for Treatment of Cystic Lesions of the Pituitary and Surrounding Areas (Sellar/Parasellar Region)
There is no consensus in the literature on the best way to treat cystic lesions of the pituitary area. Patients who are symptomatic from these tumours are rare. The cystic form of tumours present special challenges since traditional treatment modalities (surgery and/or external radiation) are often not able to completely remove or treat the cyst wall without major morbidity or even mortality.
There is no 'best practice' for the treatment of cystic tumours per se. Treatments available to patients with cystic sellar/parasellar tumours include conservative management using a 'wait and scan' approach, cyst drainage, and cyst removal via transsphenoidal and/or craniotomy approach (i.e. open surgery). Over the last 10 years we have treated approximately 8 patients with intracystic radiotherapy. All of these patients continue to be monitored clinically and radiologically and all have done well with stable regression of the cysts and no new neurological deficits. Over the past 2 years, 90yttrium colloid has been provided to CDHA through Health Canada's Special Access Program (SAP). It has only been of recent that Health Canada has requested a clinical trial to assess the benefit of intracystic radiotherapy over other available treatment options.
The experimental treatment being proposed is the stereotactic intracavitary instillation of 90yttrium colloid for treatment of cystic lesions of the pituitary (sellar) and surrounding areas (parasellar).
Read the detailed description
Surgical procedures will be performed as standard of care. The treating neurosurgeon (Dr. David B. Clarke) will determine surgical parameters based on his clinical expertise.
- Being tested
- 90yttrium colloid
- Keywords
- Rathke's cleft cyst, pituitary cysts, cystic craniopharyngiomas
- Medical subject headings
- Central Nervous System Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
90yttrium colloidRadiation
90yttrium colloid will be inserted into a sellar/parasellar cyst
| Study group | Role | What they receive |
|---|---|---|
| 90yttrium colloid | Experimental | 90 Yttrium colloid will be inserted into the cystic cavity. Based on clinical expertise, the treating neurosurgeon will determine the appropriate surgical procedure for each patient on an individual basis which will be reflected in the surgical consent the patient is presented and signs. Receives: Radiation: 90yttrium colloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cyst shrinkage
Decreased cyst volume on MRI + resolution of clinical symptoms
Measured: 12 months after treatment
Secondary outcomes (1)
Localization of intracystic 90yttrium colloid by PET-CT
Visualization of 90 yttrium colloid within the cyst
Measured: Within 3 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startJun 2014
- Primary completion30 Jun 2031 (estimated)
- Study completion31 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Tumors of the Sellar/Parasellar RegionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intracystic insertion of 90Yttrium colloid
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Clarke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Clarke, Nova Scotia Health Authority
- Investigators
- David Clarke, Principal investigator, Capital District Health Auhtority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081768
- Sponsor's protocol ID
- Yttrium2014
- Status last verified
- Feb 2026
- First submitted
- 5 Mar 2014
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. 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 Pituitary and Surrounding Areas (Sellar/Parasellar Region)
- ClinicalTrials.gov ID
- NCT02081768
- Acronym / sponsor ID
- Yttrium2014
- Keywords
- Rathke's cleft cyst, pituitary cysts, cystic craniopharyngiomas
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- David ClarkeUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 31 Oct 2031 (estimated)
- First posted
- 7 Mar 2014 (estimated)
- 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.
There is no consensus in the literature on the best way to treat cystic lesions of the pituitary area. Patients who are symptomatic from these tumours are rare. The cystic form of tumours present special challenges since traditional treatment modalities (surgery and/or external radiation) are often not able to completely remove or treat the cyst wall without major morbidity or even mortality.
There is no 'best practice' for the treatment of cystic tumours per se. Treatments available to patients with cystic sellar/parasellar tumours include conservative management using a 'wait and scan' approach, cyst drainage, and cyst removal via transsphenoidal and/or craniotomy approach (i.e. open surgery). Over the last 10 years we have treated approximately 8 patients with intracystic radiotherapy. All of these patients continue to be monitored clinically and radiologically and all have done well with stable regression of the cysts and no new neurological deficits. Over the past 2 years, 90yttrium colloid has been provided to CDHA through Health Canada's Special Access Program (SAP). It has only been of recent that Health Canada has requested a clinical trial to assess the benefit of intracystic radiotherapy over other available treatment options.
The experimental treatment being proposed is the stereotactic intracavitary instillation of 90yttrium colloid for treatment of cystic lesions of the pituitary (sellar) and surrounding areas (parasellar).
Detailed description
Surgical procedures will be performed as standard of care. The treating neurosurgeon (Dr. David B. Clarke) will determine surgical parameters based on his clinical expertise.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intracystic insertion of 90Yttrium colloid
| Arm | Type | Receives |
|---|---|---|
| 90yttrium colloid | Experimental | Radiation: 90yttrium colloid90 Yttrium colloid will be inserted into the cystic cavity. Based on clinical expertise, the treating neurosurgeon will determine the appropriate surgical procedure for each patient on an individual basis which will be reflected in the surgical consent the patient is presented and signs. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who meet all of the following criteria are eligible for enrollment as study participants:
- Patients 17 years of age or older.
- Cystic sellar, suprasellar, parasellar or intrasellar masses diagnosed by histology, cytology or neuroimaging.
- Tumour measurements and/or tumour volume can be calculated.
- Patients who require surgical intervention as determined by the treating neurosurgeon.
Key exclusion criteria (5 listed)
- Patients who meet any of these criteria are not eligible for enrollment as study participants:
- Neurosurgeon's assessment that surgical procedures hold unacceptable operative risk.
- Having a solid tumour.
- Pregnant or breast feeding at time of surgical consent and/or surgery.
- Hypersensitivity, allergies or contraindication to the used radiopharmaceutical agent (90yttrium colloid).
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 |
|---|---|---|
| 90yttrium colloid90yttrium colloid will be inserted into a sellar/parasellar cyst | Radiation | 90yttrium colloid |
Primary outcome
Cyst shrinkage
Time frame: 12 months after treatment
Decreased cyst volume on MRI + resolution of clinical symptoms
1 secondary outcome
Localization of intracystic 90yttrium colloid by PET-CT
Time frame: Within 3 weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
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.
David B. Clarke, MDCM, PhD, FRCSC, DABNS, FACS contact
David Clarke principal investigator
Capital District Health Auhtority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 90yttrium colloid in people with Cystic Tumors of the Sellar/Parasellar Region, 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 8 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 20 Feb 2026. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David B. Clarke, MDCM, PhD, FRCSC, DABNS, FACS (d.clarke@dal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cyst shrinkage (time frame: 12 months after treatment). 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 20 Feb 2026.