Quantitative Analysis of All Somatostatin Receptors and Dopamine Receptor Subtype 2 mRNA and Protein Expression Study in Non-functioning Pituitary Adenomas and Resistant Prolactinomas: Correlation With in Vitro and in Vivo Responsiveness to Somatostatin Analogs and Dopamine Agonist
The goals of this study are: to verify whether cabergoline and pasireotide are effective in
NFPA to control tumor re-growth as adjuvant therapy after neurosurgery and whether
pasireotide is capable of normalizing the prolactin levels in patients with prolactinomas
resistant to cabergoline; to assess the mRNA levels of DR2 and SSTR1-5 and their protein
expression; to evaluate the in vitro hormonal response to cabergoline, octreotide and
pasireotide; and to determine whether the mRNA DR2/SSTR1-5 and/or protein expression and/or
in vitro hormonal response to cabergoline, octreotide and pasireotide correlates with the in
vivo response to the former and to the last one. With this data the investigators intend to
establish if the mRNA analysis and/or protein expression in NFPA and resistant prolactinomas
might be predictive or foretelling factors concerning drug treatment in patients with this
kind of pituitary tumors and also evaluate if there is any response in vitro or in vivo to
the treatment with pasireotide in NFPA and resistant prolactinomas and with cabergoline in
NFPA.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Tumor volume reduction
Magnetic resonance imaging (MRI) of the sella will be performed before and after 6 months of treatment with cabergoline or pasireotide. Disease progression will be defined as tumor growth > 25%, stable disease as changes < 25% and significant tumor shrinkage as > 25% in tumor volume compared to baseline MRI.
Six months
No
Mônica R. Gadelha, PhD
Principal Investigator
Endocrinology Section - Hospital Universitário Clementino Fraga Filho/Federal University of Rio de Janeiro
Brazil: National Health Surveillance Agency
CSOM230BBR01T
NCT01620138
March 2010
June 2012
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