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

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Minor 2 versions Re-verified since Jun 5, 2025, no change to tracked fieldsv18-v19
  2. Minor Study completion date: Oct 30, 2031 to Oct 31, 2031v17
  3. Notable Primary completion date: Jun 30, 2030 to Jun 30, 2031
    • Study description expanded, about 4 words
    v16
  4. Notable Primary completion date: Jun 30, 2024 to Jun 30, 2030
    • Study completion date: Oct 30, 2025 to Oct 30, 2031
    v15
  5. Minor Study completion date: Jun 30, 2025 to Oct 30, 2025v14
Show 12 earlier versionsHide 12 earlier versions
  1. Minor Primary completion date: Jun 2024 to Jun 30, 2024v13
  2. Minor 3 versions Re-verified since Dec 11, 2020, no change to tracked fieldsv10-v12
  3. Minor Study completion date: Jun 2025 to Jun 30, 2025
    • Study description expanded, about 21 words
    v9
  4. Minor 2 versions Re-verified since Jul 16, 2018, no change to tracked fieldsv7-v8
  5. Minor Secondary endpoints: details revised at 1 of 1 entryv6
  6. Minor 2 versions Re-verified since Jan 26, 2016, no change to tracked fieldsv4-v5
  7. Minor Interventions: 90yttrium colloid will be inserted into a sellar/parasellar cyst (Radiation) to 90yttrium colloid (Radiation)v3
  8. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT02081768
Lead Sponsor David Clarke
Conditions
(from sponsor)
Cystic Tumors of the Sellar/Parasellar Region
Related terms Central Nervous System Cysts
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov