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

This study is currently recruiting participants.
Verified April 2017 by David Clarke, Nova Scotia Health Authority
Sponsor:
ClinicalTrials.gov Identifier:
NCT02081768
First Posted: March 7, 2014
Last Update Posted: April 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
David Clarke, Nova Scotia Health Authority
  Purpose

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).


Condition Intervention Phase
Cystic Tumors of the Sellar/Parasellar Region Radiation: 90yttrium colloid Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
90Yttrium colloid
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by David Clarke, Nova Scotia Health Authority:

Primary Outcome Measures:
  • Cyst shrinkage [ Time Frame: 12 months after treatment ]
    Decreased cyst volume on MRI


Secondary Outcome Measures:
  • Localization of intracystic 90yttrium colloid by PET-CT [ Time Frame: Within 3 weeks of treatment ]
    Visualization of 90 yttrium colloid within the cyst


Estimated Enrollment: 40
Study Start Date: June 2014
Estimated Study Completion Date: June 2025
Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02081768


Contacts
Contact: David B. Clarke, MDCM, PhD, FRCSC, DABNS, FACS d.clarke@dal.ca
Contact: Andrea L.O. Hebb, MSc, PhD, RN 902 473-4824 andrea.hebb@cdha.nshealth.ca

Locations
Canada, Nova Scotia
Halifax Infirmary Recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Contact: David B. Clarke, MDCM, PhD, FRCSC, DABNS, FACS    902-473-4591    d.clarke@dal.ca   
Principal Investigator: David B. Clarke, 902-473-4591         
Sponsors and Collaborators
David Clarke
Investigators
Principal Investigator: David Clarke Capital District Health Auhtority
  More Information

Responsible Party: David Clarke, Neurosurgeon, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT02081768     History of Changes
Other Study ID Numbers: Yttrium2014
First Submitted: March 5, 2014
First Posted: March 7, 2014
Last Update Posted: April 20, 2017
Last Verified: April 2017

Keywords provided by David Clarke, Nova Scotia Health Authority:
Rathke's cleft cyst
cystic craniopharyngiomas