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)

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).

Study Overview

• Status: Recruiting
• Conditions: Cystic Tumors of the Sellar/Parasellar Region
• Intervention / Treatment: Radiation: 90yttrium colloid

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: David B. Clarke, MDCM, PhD, FRCSC, DABNS, FACS; Email: d.clarke@dal.ca
• Study Contact Backup: Name: Andrea LO Hebb, PhD, RN; Phone Number: 902 473-4824; Email: andrea.hebb@nshealth.ca

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 3A7
      • Recruiting
      • Halifax Infirmary
      • Contact: David B. Clarke, MDCM, PhD, FRCSC, DABNS, FACS; Phone Number: 902-473-4591; Email: d.clarke@dal.ca
      • Principal Investigator: David B. Clarke, 902-473-4591

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Radiation: 90yttrium colloid; 90yttrium colloid will be inserted into a sellar/parasellar cyst

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cyst shrinkage	Decreased cyst volume on MRI	12 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Localization of intracystic 90yttrium colloid by PET-CT	Visualization of 90 yttrium colloid within the cyst	Within 3 weeks of treatment

Collaborators and Investigators

• Sponsor: David Clarke
• Investigators: Principal Investigator: David Clarke, Capital District Health Auhtority

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): October 30, 2031

Study Registration Dates

• First Submitted: March 5, 2014
• First Submitted That Met QC Criteria: March 6, 2014
• First Posted (Estimated): March 7, 2014

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Rathke's cleft cyst; cystic craniopharyngiomas
• Other Study ID Numbers: Yttrium2014