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

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)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02081768
Enrollment
40
Registered
2014-03-07
Start date
2014-06-01
Completion date
2031-10-31
Last updated
2026-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Tumors of the Sellar/Parasellar Region

Keywords

Rathke's cleft cyst, pituitary cysts, cystic craniopharyngiomas

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.

Interventions

RADIATION90yttrium colloid

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

Sponsors

David Clarke
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

Open label, patients assigned to treatment group

Intervention model description

Intracystic insertion of 90Yttrium colloid

Eligibility

Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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).

Design outcomes

Primary

MeasureTime frameDescription
Cyst shrinkage12 months after treatmentDecreased cyst volume on MRI + resolution of clinical symptoms

Secondary

MeasureTime frameDescription
Localization of intracystic 90yttrium colloid by PET-CTWithin 3 weeks of treatmentVisualization of 90 yttrium colloid within the cyst

Countries

Canada

Contacts

CONTACTDavid B. Clarke, MDCM, PhD, FRCSC, DABNS, FACS
d.clarke@dal.ca
CONTACTAndrea LO Hebb, PhD, RN
andrea.hebb@nshealth.ca902 473-4824
PRINCIPAL_INVESTIGATORDavid Clarke

Capital District Health Auhtority

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026