Clinical Trial Finder

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

Study 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).

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


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Study Type
Interventional
Eligible Ages 17 Years and Over
Gender All
More Inclusion & Exclusion 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).

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02081768

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 3

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
David Clarke

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
David Clarke
Principal Investigator Affiliation Capital District Health Auhtority

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Other
Overall Status Recruiting
Countries Canada

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Cystic Tumors of the Sellar/Parasellar Region

Contact a Trial Team

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International Sites

Halifax Infirmary, Halifax, Nova Scotia, Canada

Status

Recruiting

Address

Halifax Infirmary

Halifax, Nova Scotia, B3H 3A7

Site Contact

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

d.clarke@dal.ca

902-473-4591

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