90Yttrium Colloid for the Treatment of Cystic Sellar/Parasellar Tumors

Phase 3

Recruiting

• Conditions: Cystic Tumors of the Sellar/Parasellar Region

• Registration Number: NCT02081768
• Lead Sponsor: David Clarke

Brief 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 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 Timeline

• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-06
• Study First Posted: 2014-03-07
• Study Start: 2014-06
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-05
• Last Update Posted: 2025-06-08
• Primary Completion: 2031-06-30
• Study Completion: 2031-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Cyst shrinkage	12 months after treatment	Decreased cyst volume on MRI + resolution of clinical symptoms

Secondary Outcome Measures

Name	Time	Method
Localization of intracystic 90yttrium colloid by PET-CT	Within 3 weeks of treatment	Visualization of 90 yttrium colloid within the cyst

Trial Locations

Locations (1)

Halifax Infirmary; 🇨🇦 Halifax, Nova Scotia, Canada