The GALANT trial: study protocol of a randomised placebo-controlled trial in patients with a 68 Ga -DOTATATE PET-positive, clinically non-functioning pituitary macroadenoma on the effect of lan reotide on t umour size.

Autor:	Boertien TM; Department of Endocrinology and Metabolism, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands t.m.boertien@amsterdamumc.nl., Drent ML; Department of Internal Medicine, Section of Endocrinology, Amsterdam UMC, location VUMC, VU University, Amsterdam, The Netherlands., Booij J; Department of Radiology and Nuclear Medicine, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands., Majoie CBLM; Department of Radiology and Nuclear Medicine, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands., Stokkel MPM; Department of Nuclear Medicine, Netherlands Cancer Institute, Amsterdam, The Netherlands., Hoogmoed J; Department of Neurosurgery, Neurosurgical Centre Amsterdam, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands., Pereira A; Department of Medicine, Division of Endocrinology, and Centre for Endocrine Tumors Leiden (CETL), Leiden University Medical Centre, Leiden, The Netherlands., Biermasz NR; Department of Medicine, Division of Endocrinology, and Centre for Endocrine Tumors Leiden (CETL), Leiden University Medical Centre, Leiden, The Netherlands., Simsek S; Department of Internal Medicine, Section of Endocrinology, Amsterdam UMC, location VUMC, VU University, Amsterdam, The Netherlands.; Department of Internal Medicine, Northwest Clinics, Alkmaar, The Netherlands., Groote Veldman R; Department of Internal Medicine, Medical Spectrum Twente, Enschede, The Netherlands., Tanck MWT; Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands., Fliers E; Department of Endocrinology and Metabolism, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands., Bisschop PH; Department of Endocrinology and Metabolism, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, location AMC, University of Amsterdam, Amsterdam, The Netherlands.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2020 Aug 13; Vol. 10 (8), pp. e038250. Date of Electronic Publication: 2020 Aug 13.
DOI:	10.1136/bmjopen-2020-038250
Abstrakt:	Introduction: At present, there is no approved medical treatment option for patients with non-functioning pituitary adenoma. A number of open-label studies suggest that treatment with somatostatin analogues may prevent tumour progression. In vivo somatostatin receptor imaging using 68 Ga-DOTATATE PET (PET, positron emission tomography) could help in preselecting patients potentially responsive to treatment. Our aim is to investigate the effect of the somatostatin analogue lanreotide as compared with placebo on tumour size in patients with a 68 Ga-DOTATATE PET-positive non-functioning pituitary macroadenoma (NFMA). Methods and Analysis: The GALANT study is a multicentre, randomised, double-blind, placebo-controlled trial in adult patients with a suprasellar extending NFMA. Included patients undergo a 68 Ga-DOTATATE PET/CT of the head and tracer uptake is assessed after coregistration with pituitary MRI. Forty-four patients with a 68 Ga-DOTATATE PET-positive NFMA are randomised in a 1:1 ratio between lanreotide 120 mg or placebo, both administered as subcutaneous injections every 28 days for 72 weeks. The primary outcome is the change in cranio-caudal tumour diameter on pituitary MRI after treatment. Secondary outcomes are change in tumour volume, time to tumour progression, change in quality of life and number of adverse events. Final results are expected in the second half of 2021. Ethics and Dissemination: The study protocol has been approved by the Medical Research Ethics Committee of the Academic Medical Centre (AMC) of the Amsterdam University Medical Centres and by the Dutch competent authority. It is an investigator-initiated study with financial support by Ipsen Farmaceutica BV. The AMC, as sponsor, remains owner of all data. Results will be submitted for publication in a peer-reviewed journal. Trial Registration Number: NL5136 (Netherlands Trial Register); pre-recruitment. Competing Interests: Competing interests: MLD received a honorarium for chairing a symposium sponsored by Ipsen Farmaceutica BV in 2019. (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)
Databáze:	MEDLINE
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