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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02288962
Other study ID # 2012/677
Secondary ID 2012-001338-32
Status Recruiting
Phase Phase 3
First received
Last updated
Start date November 2014
Est. completion date December 2027

Study information

Verified date June 2024
Source St. Olavs Hospital
Contact Stine L Fougner, md phd
Email stine.fougner@ntnu.no
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Due to lack of hormone overproduction in non-functioning pituitary adenomas (NFPAs), only the symptomatic adenomas or large adenomas with proven growth and risk for symptoms in near future will undergo pituitary surgery. The remaining adenomas are monitored regularly. Operation of these large adenomas will rarely remove all tumour tissue, and there is also a risk of worsening of pituitary function. Often, adenomas with the highest growth potential are operated several times and some also need radiation therapy, providing additional risk for pituitary failure. Unlike some of the hormone-producing adenomas, there is no established pharmacological treatment for NFPAs. However, there are a few non-randomized studies suggesting that treatment with dopamine agonists may slow growth, and also induce tumour shrinkage. At present, cabergoline is the dopamine agonist most widely used in the treatment of pituitary adenomas secreting prolactin. Aim is to study the effect of medical treatment with cabergoline in non-functioning pituitary adenomas on the change in tumour volume.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2027
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
cabergoline


Locations

Country Name City State
Norway Department of Endocrinology, Akershus University hospital Oslo
Norway Department of Endocrinology, St. Olavs Hospital Trondheim
Sweden Sahlgrenska University Hospital Gøteborg

Sponsors (2)

Lead Sponsor Collaborator
St. Olavs Hospital Norwegian University of Science and Technology

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in tumour volume during the main study of two years This includes the percentage and absolute change in tumour volume, but also the number of patients with significant tumour shrinkage or tumour growth (defined by = 10 % or = 2 mm shrinkage/growth in at least one dimension) 2 years
Secondary need for surgical and/or radiation treatment up till 2 years
Secondary changed pituitary function measured by analysis of blood tests, basal and stimulation tests up till 2 years
Secondary change in tumour's distance to chiasma opticum in mm as measured by analysis of MRI images up till 2 years
Secondary development of cardiac valvulopathy as measured by analysis of echo cardiography up till 2 years
Secondary impulse control disorder as measured by questionnaire visual files: clinical evaluation by ophthalmologist and perimetry up till 2 years
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