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

NCT02081768 | Recruiting Phase 3 DMC

• 1 other identifier: Yttrium2014
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Rathke's cleft cyst, pituitary cysts; cystic craniopharyngiomas

Outcome Measures

Primary Outcomes (1)

• Cyst shrinkage

  Decreased cyst volume on MRI + resolution of clinical symptoms

  12 months after treatment

Secondary Outcomes (1)

• Localization of intracystic 90yttrium colloid by PET-CT

  Within 3 weeks of treatment

Study Arms (1)

90yttrium colloid

EXPERIMENTAL

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.

Radiation: 90yttrium colloid

Interventions

90yttrium colloid RADIATION

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

90yttrium colloid

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• David Clarke: lead

Study Sites (1)

Halifax Infirmary

Halifax, Nova Scotia, B3H 3A7, Canada

RECRUITING

MeSH Terms

Conditions

Central Nervous System Cysts

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• David Clarke

  Capital District Health Auhtority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

d.clarke@dal.ca

Andrea LO Hebb, PhD, RN

CONTACT

902 473-4824; andrea.hebb@nshealth.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: Open label, patients assigned to treatment group
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Neurosurgeon

Model Details: Intracystic insertion of 90Yttrium colloid

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 7, 2014
• Study Start: June 1, 2014
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): October 31, 2031
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

CA (1)