90Yttrium Colloid for the Treatment of Cystic Sellar/Parasellar Tumors
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|ClinicalTrials.gov Identifier: NCT02081768|
Recruitment Status : Recruiting
First Posted : March 7, 2014
Last Update Posted : February 1, 2019
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).
|Condition or disease||Intervention/treatment||Phase|
|Cystic Tumors of the Sellar/Parasellar Region||Radiation: 90yttrium colloid||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||90Yttrium colloid|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||June 2024|
|Estimated Study Completion Date :||June 2025|
Experimental: 90yttrium colloid
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.
Radiation: 90yttrium colloid
90yttrium colloid will be inserted into a sellar/parasellar cyst
- Cyst shrinkage [ Time Frame: 12 months after treatment ]Decreased cyst volume on MRI
- Localization of intracystic 90yttrium colloid by PET-CT [ Time Frame: Within 3 weeks of treatment ]Visualization of 90 yttrium colloid within the cyst
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02081768
|Contact: David B. Clarke, MDCM, PhD, FRCSC, DABNS, FACSfirstname.lastname@example.org|
|Contact: Andrea L.O. Hebb, MSc, PhD, RN||902 email@example.com|
|Canada, Nova Scotia|
|Halifax, Nova Scotia, Canada, B3H 3A7|
|Contact: David B. Clarke, MDCM, PhD, FRCSC, DABNS, FACS 902-473-4591 firstname.lastname@example.org|
|Principal Investigator: David B. Clarke, 902-473-4591|
|Principal Investigator:||David Clarke||Capital District Health Auhtority|