ECE2020 ePoster Presentations Pituitary and Neuroendocrinology (94 abstracts)
The galant trial: a randomised placebo-controlled trial in patients with a gallium-68 dotatate pet positive, clinically non-functioning pituitary macroadenoma on the effect of lanreotide on tumour size
Tessel M. Boertien 1 , M.L. Drent 2 , Jan Booij 3 , Charles B.L.M. Majoie 3 , Marcel P.M. Stokkel 4 , Jantien Hoogmoed 5 , Alberto M Pereira 6 , Nienke Biermasz 6 , Suat Simsek 2,7 , Ronald Groote Veldman 8 , Michael W.T. Tanck 9 , Eric Fliers 1 & Peter H. Bisschop 1
1Amsterdam UMC, University of Amsterdam, Endocrinology & Metabolism, Amsterdam, Netherlands; 2Amsterdam UMC, VU University, Internal Medicine, Section of Endocrinology, Amsterdam, Netherlands; 3Amsterdam UMC, University of Amsterdam, Radiology and Nuclear Medicine, Amsterdam, Netherlands; 4Netherlands Cancer Institute (NKI), Nuclear Medicine, Amsterdam, Netherlands; 5Amsterdam UMC, University of Amsterdam, Neurosurgery, Amsterdam, Netherlands; 6Leiden University Medical Center (LUMC), Internal Medicine, Center for Endocrine Tumors Leiden (CETL), Leiden, Netherlands; 7Northwest Clinics (NWZG), Internal Medicine, Alkmaar, Netherlands; 8Medical Spectrum Twente (MST), Internal Medicine, Enschede, Netherlands; 9Amsterdam UMC, University of Amsterdam, Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam, Netherlands
Rationale: At present, there is no approved medical treatment for patients with clinically non-functioning pituitary adenoma. A number of open-label studies suggest that treatment with somatostatin analogues may prevent tumour progression in selected patients. In vivo assessment of somatostatin receptor status using 68Ga-DOTATATE PET could help to select patients responsive to treatment.
Trial objective: To investigate the effect of the somatostatin analogue lanreotide as compared to placebo on tumour size in patients with a 68Ga-DOTATATE PET-positive non-functioning pituitary macroadenoma (NFMA).
Design: The GALANT study is an investigator-initiated, multicentre, randomised, double-blind, placebo-controlled trial in adult patients with a suprasellar extending NFMA, either surgery-naïve or as postoperative remnant. Included patients undergo 68Ga-DOTATATE PET/CT of the head and tracer uptake is assessed after coregistration with pituitary MRI. Forty-four patients with a 68Ga-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 size after treatment assessed with pituitary MRI. Secondary outcomes are change in tumour volume, time to tumour progression, change in quality of life and number of adverse events. The study protocol has been approved by the medical research ethics committee of the Academic Medical Centre of the Amsterdam University Medical Centres and by the Dutch competent authority. Financial support is provided by Ipsen Farmaceutica BV.
Conclusion: The GALANT study is the first double-blind and placebo-controlled intervention trial in NFMA patients. Inclusion has been completed and results are expected in the second half of 2021. If lanreotide is effective in reducing or controlling tumour size, this would present an important new treatment option for NFMA patients.
Trial registration: EudraCT 2015–001234–22, registered 10 March 2015, and Netherlands Trial Register NL5136, registered 18 August 2015. Registration took place before start of recruitment.
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Endocrine Abstracts
ISSN 1470-3947 (print) | ISSN 1479-6848 (online)
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