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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 90yttrium colloid | Radiation | 90yttrium colloid will be inserted into a sellar/parasellar cyst |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cyst shrinkage | Decreased cyst volume on MRI + resolution of clinical symptoms | 12 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Localization of intracystic 90yttrium colloid by PET-CT | Visualization of 90 yttrium colloid within the cyst | Within 3 weeks of treatment |
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Criteria
Ages Eligible for Study: 17 years of age or older Genders Eligible for Study: Both Accepts Healthy Volunteers: No
Inclusion Criteria
Patients who meet all of the following criteria are eligible for enrollment as study participants:
Exclusion Criteria
Patients who meet any of these criteria are not eligible for enrollment as study participants:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David B. Clarke, MDCM, PhD, FRCSC, DABNS, FACS | Contact | d.clarke@dal.ca | ||
| Andrea LO Hebb, PhD, RN | Contact | 902 473-4824 | andrea.hebb@nshealth.ca |
| Name | Affiliation | Role |
|---|---|---|
| David Clarke | Capital District Health Auhtority | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Halifax Infirmary | Recruiting | Halifax | Nova Scotia | B3H 3A7 | Canada |
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| ID | Term |
|---|---|
| D020863 | Central Nervous System Cysts |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Intracystic insertion of 90Yttrium colloid
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Open label, patients assigned to treatment group
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| D009421 |
| Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |