The effect of lanreotide on non-functioning pituitary macroadenoma size

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 (GALANT)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27861

Enrollment

Registered

2015-07-14

Start date

2015-11-03

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pituitary adenoma hypofyse adenoom

Interventions

Gallium-68 DOTATATE PET/CT > positive PET/CT: randomization: Group 1 monthly subcutaneous injections of somatostatin analog (18 months) Group 2 monthly subcutaneous injections of placebo (18 month

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients (>18 yrs) Clinically non-functioning pituitary macroadenoma with suprasellar extension [Positive PET/CT scan > this is a study procedure, performed after patient inclusion]

Exclusion criteria

Exclusion criteria: Optic chiasm compression with visual field defects Hypersensitivity for somatostatin or similar peptides Obstructive neuroendocrine gut tumor Previous radiation therapy in the pituitary region Known symptomatic cholelithiasis Use of dopamine agonists or somatostatin analogues in the past 6 months Pregnancy (plans) Any contraindication to perform MRI with gadolinium based contrast agent

Design outcomes

Primary

Measure	Time frame
Change in cranio-caudal NFMA size	—

Secondary

Measure	Time frame
Adverse events (AE’s) Change in quality of life Change in NFMA volume	—

Contacts

Public ContactTessel Boertien

Academic Medical Center - Department of Endocrinology & Metabolism, K2-283

t.m.boertien@amsterdamumc.nl020-5660172 / 020-5666071

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)