Recruiting
Phase 3

90Yttrium Colloid

Sponsor:

David Clarke

Code:

NCT02081768

Conditions

Cystic Tumors of the Sellar/Parasellar Region

Eligibility Criteria

Sex: All

Age: 17+

Healthy Volunteers: Not accepted

Interventions

90yttrium colloid

Study Details

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).

Conditions

Cystic Tumors of the Sellar/Parasellar Region

Study ID

NCT02081768

Start date

Jun, 2014

Status verified date

Feb, 2026

Completion date

Oct 31, 2031

Anticipated

Primary completion date

Jun 30, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 17+

Healthy Volunteers: Not accepted

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:

1. Patients 17 years of age or older.
2. Cystic sellar, suprasellar, parasellar or intrasellar masses diagnosed by histology, cytology or neuroimaging.
3. Tumour measurements and/or tumour volume can be calculated.
4. Patients who require surgical intervention as determined by the treating neurosurgeon.
5. Being a patient managed in the Halifax Neuropituitary Program surgical clinic.
6. Willingness to undergo surgery and give informed surgical consent.
7. 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:

1. Neurosurgeon's assessment that surgical procedures hold unacceptable operative risk.
2. Having a solid tumour.
3. Pregnant or breast feeding at time of surgical consent and/or surgery.
4. Hypersensitivity, allergies or contraindication to the used radiopharmaceutical agent (90yttrium colloid).

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

90yttrium colloid

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

Primary outcome measure

  • Cyst shrinkage [ Time Frame: 12 months after treatment ]

Central Contacts and Locations

Central contacts

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

d.clarke@dal.ca

Locations

Halifax Infirmary

Recruiting

Halifax, Nova Scotia, Canada, B3H 3A7

Contacts

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

902-473-4591d.clarke@dal.ca

Principal Investigator:

David B. Clarke, 902-473-4591

More Information

Sponsor

David Clarke

Last update posted

Feb 20, 2026

Last verified

Feb, 2026

Keywords

  • Rathke's cleft cyst, pituitary cysts
  • cystic craniopharyngiomas

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by David Clarke on 2026-02-20.