Cabergoline for Non-functioning pituitary adenoma

Inclusion criteria

• {"criterion_text":"- 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

• {"criterion_text":"- 1.\tClear indication for surgery at the time of inclusion\n- 2.\tPrevious radiation therapy\n- 3.\tPituitary surgery the last 6 months\n- 4.\tPrevious apoplexy/bleeding in the adenoma\n- 5.\tPregnancy or lactation\n- 6.\tContraindications for cabergoline treatment •\tKnown cardiac valvular disease • \tKnown pulmonal, pericardial or retroperitoneal fibrosis •\tClinical significant liver insufficiency •\tUse of medications that interact with cabergoline\n- 7.\tUnfit to participate due to any other reason"}

Primary endpoints

• {"endpoint_text":"- \tThe 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).","definition_or_measurement_approach":"Change in tumour volume over two years, including percentage and absolute change; number of patients with significant tumour shrinkage or growth defined by ≥10% or ≥2 mm shrinkage/growth in at least one dimension."}

Secondary endpoints

• {"endpoint_text":"- The need for surgical and/or radiation treatment during the study period\n- The development of new pituitary failure or changed pituitary function during the study, or new or changed visual field defects or other cranial nerve affections\n- The change in tumour’s distance to chiasma opticum (mm)\n- The response on gonadotropins (FSH, LH) and/or their subunits, particularly the α-subunit. A possible correlation between the tumour size response and the hormone levels and change during treatment","definition_or_measurement_approach":"Assessment of requirement for surgery/radiation; monitoring of pituitary function and visual/cranial nerve status; measurement of tumour distance to chiasma opticum in mm; measurement of gonadotropins (FSH, LH) and subunits (particularly α-subunit) and analysis of correlation between hormone changes and tumour size response."}

Norway

Earliest CTIS Part Ii Submission Date

08-11-2024

Latest Decision Or Authorization Date

18-11-2024

Processing Time Days

10

Number Of Sites

2

Number Of Participants

60

Primary sponsor

Full Name

St. Olavs Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway