The effect of lanreotide on non-functioning pituitary macroadenoma size

Phase 1

• Conditions: Clinically non-functioning pituitary macroadenoma; MedDRA version: 20.0Level: PTClassification code 10029556Term: Non-secretory adenoma of pituitarySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2015-001234-22-NL
• Lead Sponsor: Academic Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-02
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

•NFMA with suprasellar extension (in previously operated patients: residual adenoma or recurrence > 10 mm)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

Exclusion Criteria

•Hypersensitivity for somatostatin or similar peptides
•Optic chiasm compression with visual field defects (this is an operation indication)
•Obstructive neuroendocrine gut tumor
•Previous radiation therapy in the pituitary region
•Symptomatic and proven cholelithiasis
•Use of dopamine agonists in the past 6 months
•Use of somatostatin analogues in the past 6 months
•Pregnancy (plans)
•Any contraindication to perform MRI with gadolinium-based contrast agent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified