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

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

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50502

Enrollment

Registered

2015-06-25

Start date

2015-11-03

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

pituitary adenoma pituitary tumor

Interventions

A Gallium-68 DOTATATE PET/CT will be performed in suitable patients after obtaining informed consent. The first 44 patients with a positive PET/CT will be randomized into two treatment groups: Group

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Clinically non-functioning pituitary macroadenoma, or post-surgical residue/recurrence >

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
* Change in cranio-caudal NFMA size	—

Secondary

Measure	Time frame
* Adverse events (AEs) Change in quality of life * Change in NFMA volume * Time to progression (tumor growth)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)