Treatment of cystic tumors in the pituitary area using 90Yttrium colloid
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)
This study is testing if a new treatment using 90Yttrium colloid can help shrink cystic tumors in the pituitary area for patients who have already had surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 17 Years and up |
| Sex | All |
| Sponsor | Nova Scotia Health Authority Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Halifax, Nova Scotia) |
| Trial ID | NCT02081768 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of 90Yttrium colloid as a treatment for cystic tumors located in the sellar and parasellar regions. The study aims to provide an alternative to traditional surgical and radiation therapies, which often come with significant risks and complications. Patients eligible for the trial will undergo standard surgical procedures as determined by the treating neurosurgeon, followed by the administration of the 90Yttrium colloid. The trial will monitor the effectiveness of this treatment in reducing tumor size and improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 17 and older with cystic sellar, suprasellar, or parasellar masses requiring surgical intervention.
Not a fit: Patients with solid tumors or those deemed by the neurosurgeon to have unacceptable surgical risks will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a safer and more effective option for patients with cystic sellar/parasellar tumors.
How similar studies have performed: While there is limited consensus on the best treatment for these tumors, previous cases of intracystic radiotherapy have shown promising results, suggesting potential success for this novel approach.
Eligibility criteria
Show full 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).
Where this trial is running
Halifax, Nova Scotia
- Halifax Infirmary — Halifax, Nova Scotia, Canada (Recruiting)
Study contacts
- Principal investigator: David Clarke — Capital District Health Auhtority
- Study coordinator: David B. Clarke, MDCM, PhD, FRCSC, DABNS, FACS
- Email: d.clarke@dal.ca
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.