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The effect of lanreotide on non-functioning pituitary macroadenoma size


- candidate number22454
- NTR NumberNTR5275
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jul-2015
- Secondary IDsNL52821.018.15 
- Public TitleThe effect of lanreotide on non-functioning pituitary macroadenoma size
- Scientific TitleA 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)
- ACRONYMGALANT
- hypothesissomatostatin therapy can reduce tumor size in certain types of pituitary NFMA
- Healt Condition(s) or Problem(s) studiedPituitary adenomas
- Inclusion criteriaAdult patients (>18 yr)
Clinically non-functioning pituitary macroadenoma with suprasellar extension
Positive PET/CT scan
- Exclusion criteriaOptic chiasm compression and/or visual field defects
Hypersensitivity for somatostatin or similar peptides
Obstructive neuroendocrine gut tumor
Known cholelithiasis
Use of dopamine agonists
Pregnancy (plans)
Any contraindication to perform MRI with gadolinium based contrast agent
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-aug-2015
- planned closingdate31-dec-2018
- Target number of participants96
- InterventionsPET/CT
positive PET/CT: randomization:
Group 1 monthly subcutaneous injections of somatostatin analog (18 months)
Group 2 monthly subcutaneous injections of placebo (18 months)
- Primary outcomeChange in cranio-caudal NFMA size
- Secondary outcomeAdverse events (AEs)
Change in quality of life
Change in NFMA volume
- Timepointsbaseline, 12 months % 18 months
AE's will be registered continuously
- Trial web sitewww.studies-endocrinologie.nl/hypofyse/galant/
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES T.M. Boertien
- CONTACT for SCIENTIFIC QUERIESProf. dr. E. Fliers
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Ipsen Farmatherapeutica bv
- Publications
- Brief summaryIn patients with clinically non-functioning pituitary macroadenomas (NFMA), the current therapeutic approach is to substitute any hormonal deficits, and to perform transsphenoidal surgery if necessary. The available evidence concerning treatment and follow-up of NFMA is based exclusively on small, observational studies. It has been known for some decades that NFMA may express somatostatin receptors, as seen in surgical specimens and in vivo, using Indium-111 pentetreotide SPECT. We hypothesize that positive somatostatin receptor imaging with Gallium-68 DOTATATE PET/CT in pituitary NFMA predicts response to somatostatin analogue therapy and that this therapy will reduce the growth rate and/or tumor size in NFMA patients.
- Main changes (audit trail)7-okt-2017 -IK:
Exclusion criteria:
"Optic chiasm compression and/or visual field defects
Hypersensitivity for somatostatin or similar peptides
Obstructive neuroendocrine gut tumor
Known cholelithiasis
Use of dopamine agonists
Pregnancy (plans)
Any contraindication to perform MRI with gadolinium based contrast agent"

replaced by

"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"
- RECORD14-jul-2015 - 7-okt-2017


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