A randomized placebo-controlled study in patients with a Gallium-68 DOTATATE PET/CT positive, clinically non-functioning pituitary macroadenoma (NFMA) of the effect of Lanreotide autosolution on Tumor (adenoma) size
Phase 3
Completed
- Conditions
- pituitary adenomapituitary tumor1002111210014710
- Registration Number
- NL-OMON50502
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 66
Inclusion Criteria
* Clinically non-functioning pituitary macroadenoma, or post-surgical
residue/recurrence ><= 10mm, with suprasellar extension
Exclusion Criteria
* Optic chiasm compression and/or visual field defects
* Hypersensitivity for somatostatin or similar peptides
* Obstructive neuroendocrine gut tumor
* Symptomatic 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
(including implanted metallic devices, impaired renal function and severe
claustrophobia)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* Change in cranio-caudal NFMA size</p><br>
- Secondary Outcome Measures
Name Time Method <p>* Adverse events (AE*s)<br /><br>* Change in quality of life<br /><br>* Change in NFMA volume<br /><br>* Time to progression (tumor growth)</p><br>