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

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ClinicalTrials.gov Identifier: NCT02081768
Recruitment Status : Recruiting
First Posted : March 7, 2014
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
David Clarke, Nova Scotia Health Authority

Tracking Information
First Submitted Date  ICMJE March 5, 2014
First Posted Date  ICMJE March 7, 2014
Last Update Posted Date February 1, 2019
Study Start Date  ICMJE June 2014
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2017)
Cyst shrinkage [ Time Frame: 12 months after treatment ]
Decreased cyst volume on MRI
Original Primary Outcome Measures  ICMJE
 (submitted: March 6, 2014)
Cyst shrinkage [ Time Frame: 12 months after treatment ]
Change History Complete list of historical versions of study NCT02081768 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2017)
Localization of intracystic 90yttrium colloid by PET-CT [ Time Frame: Within 3 weeks of treatment ]
Visualization of 90 yttrium colloid within the cyst
Original Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2014)
Localization of intracystic 90yttrium colloid by PET-CT [ Time Frame: Within 3 weeks of treatment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 90Yttrium Colloid for the Treatment of Cystic Sellar/Parasellar Tumors
Official Title  ICMJE 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)
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
90Yttrium colloid
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cystic Tumors of the Sellar/Parasellar Region
Intervention  ICMJE Radiation: 90yttrium colloid
90yttrium colloid will be inserted into a sellar/parasellar cyst
Study Arms  ICMJE 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.
Intervention: Radiation: 90yttrium colloid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 6, 2014)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2025
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02081768
Other Study ID Numbers  ICMJE Yttrium2014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Clarke, Nova Scotia Health Authority
Study Sponsor  ICMJE David Clarke
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Clarke Capital District Health Auhtority
PRS Account Nova Scotia Health Authority
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP