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NCT Number: NCT02081768

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

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).

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Key information

Conditions

Cystic Tumors of the Sellar/Parasellar Region Central Nervous System Cysts Central Nervous System Neoplasms Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Malformations Nervous System Neoplasms

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Halifax Infirmary

Halifax, Nova Scotia, B3H 3A7, Canada

Location status: Recruiting

Location contact

David B. Clarke, 902-473-4591

PRINCIPAL_INVESTIGATOR

David B. Clarke, MDCM, PhD, FRCSC, DABNS, FACS

CONTACT

[email protected]

902-473-4591

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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.

Exclusion criteria

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).

Treatment and study plan

90yttrium colloid

Radiation

90yttrium colloid will be inserted into a sellar/parasellar cyst

Primary outcomes

  1. Cyst shrinkage

    Time frame: 12 months after treatment

    Decreased cyst volume on MRI + resolution of clinical symptoms

Secondary outcomes

  1. Localization of intracystic 90yttrium colloid by PET-CT

    Time frame: Within 3 weeks of treatment

    Visualization of 90 yttrium colloid within the cyst

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea LO Hebb, PhD, RN

CONTACT

[email protected]

902 473-4824

David B. Clarke, MDCM, PhD, FRCSC, DABNS, FACS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

David Clarke

Other

Registry information

Official study 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)

Important dates

Study start
2014
Primary completion
2031
Study completion
2031
First posted
Mar 7, 2014
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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