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Recruiting NCT02081768

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

Phase III Interventional Cystic Tumors of the Sellar/Parasellar Region

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 90yttrium colloid.
Who it may be relevant to
Registry conditions: Cystic Tumors of the Sellar/Parasellar Region. Basic parameters: from 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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)

Overview

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

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

Primary outcome measures

  • Cyst shrinkage [Time frame: 12 months after treatment]
Secondary outcome measures (1)
  • Localization of intracystic 90yttrium colloid by PET-CT [Time frame: Within 3 weeks of treatment]

Eligibility 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:

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Halifax Infirmary — Halifax

Identifiers

NCT: NCT02081768 · Yttrium2014

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗