Treatment of non-functioning pituitary adenomas with cabergoline
Dopamine Agonist Treatment of Non-functioning Pituitary Adenomas (NFPAs) - a Randomized Controlled Trial
This study is testing if cabergoline can help shrink or slow the growth of non-functioning pituitary adenomas in patients who haven't been treated or still have tumor growth after surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | St. Olavs Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 3 sites (Oslo and 2 other locations) |
| Trial ID | NCT02288962 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of cabergoline, a dopamine agonist, for treating non-functioning pituitary adenomas (NFPAs) that are either untreated or have residual growth after surgery. The study aims to determine if cabergoline can slow tumor growth or induce shrinkage in patients with large adenomas. Participants will be monitored through MRI scans to assess the effectiveness of the treatment. The trial focuses on patients with specific criteria related to the size and growth of their adenomas.
Who should consider this trial
Good fit: Ideal candidates include individuals with untreated non-functioning pituitary macroadenomas or those with residual adenomas after surgery that meet specific size and growth criteria.
Not a fit: Patients with clear indications for surgery or those who have had recent radiation therapy or surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-surgical option for managing non-functioning pituitary adenomas, potentially reducing the need for invasive procedures.
How similar studies have performed: Previous non-randomized studies have suggested that dopamine agonists like cabergoline may be effective in slowing the growth of non-functioning pituitary adenomas, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * A previously untreated non-functioning pituitary macroadenoma (largest diameter ≥ 10 mm) with either demonstrated growth on repeated MRI scans or ≤ 2 mm distance to chiasma opticum, or: * a residual non-functioning pituitary adenoma after surgery (largest diameter ≥ 5 mm) that is either extrasellar and/or with documented growth after surgical treatment of a non-functioning pituitary macroadenoma Exclusion Criteria: * Clear indication for surgery at the time of inclusion * Previous radiation therapy * Pituitary surgery the last 6 months * Previous apoplexy/bleeding in the adenoma * Pregnancy or lactation * Contraindications for cabergoline treatment (Known cardiac valvular disease, known pulmonal, pericardial or retroperitoneal fibrosis, clinical significant liver insufficiency, use of medications that interact with cabergoline * unfit to participate due to any other reason
Where this trial is running
Oslo and 2 other locations
- Department of Endocrinology, Akershus University hospital — Oslo, Norway (Recruiting)
- Department of Endocrinology, St. Olavs Hospital — Trondheim, Norway (Recruiting)
- Sahlgrenska University Hospital — Gøteborg, Sweden (Recruiting)
Study contacts
- Principal investigator: Sven M Carlsen, prof md — Norwegian University of Science and Technology
- Study coordinator: Stine L Fougner, md phd
- Email: stine.fougner@ntnu.no
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.