Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients...
Non-functioning Pituitary AdenomaThis study assessed pasireotide LAR efficacy on patients with non-functioning pituitary adenomas concerning tumor growth.
Cabergoline in Nonfunctioning Pituitary Adenomas
Pituitary AdenomaNonfunctioning Pituitary AdenomaClinically nonfunctioning pituitary adenoma remains the only pituitary tumor subtype for which no effective medical therapy is available or recommended. We will evaluate the use of cabergoline in a clinical trial, in order to define the efficacy of this treatment in nonfunctioning pituitary adenoma.
Transnasal Endoscopic Pituitary Surgery - the Effect of Posterior Nasal Septum Resection on Nasal...
Pituitary AdenomaThe aim of the project is to compare the effect of different extent of resection of the posterior part of the septum on the postoperative nasal functions.
Targeted Therapy With Lapatinib in Patients With Recurrent Pituitary Tumors Resistant to Standard...
Pituitary AdenomasProlactinomasThis study focuses on new therapies for a challenging disease in pituitary medicine, that of aggressive pituitary tumors which have limited therapeutic options beyond standard surgical, radiotherapy, and select medical therapies, each incurring significant morbidity and mortality, and each not optimally effective. To improve this gap in knowledge, we seek to translate findings from the laboratory into clinical practice and hone in on therapies directed at pituitary molecular targets, namely ErbB receptors. We have shown that human prolactinomas express nuclear EGFR and membranous ErbB2, ErbB3 and ErbB4, and expression correlates with tumor invasion. Pituitary tumor cell lines transfected with EGFR and ErbB2 translated to downstream effects on prolactin (PRL) gene expression and secretion,as well as cell proliferation. Animal models implanted with these cell lines developed larger tumors and PRL elevations. Treatment with ErbB tyrosine kinase inhibitors (TKIs) led to regression of tumors xenografted into these animals and attenuated PRL secretion. Primary culture of human prolactinomas confirmed expression of ErbB receptors and inhibitory effects of TKIs on PRL secretion and cell proliferation. Based on these exciting preliminary data, the objective of this new proposal is to conduct a Phase IIa clinical trial as a trenchant test of our translational hypothesis that tyrosine kinase inhibition constitutes highly effective targeted biologic therapy for these hitherto refractory pituitary adenomas. Specifically, our aims are to test the: 1) efficacy of TKI therapy with a clinical trial; 2) threshold level of tumor receptor expression to achieve TKI clinical response. Nineteen subjects will be treated with lapatinib for 6 months in combination with their current dopamine agonist therapy, with monthly measurements of PRL levels and MRI imaging every 3 months to evaluate the primary endpoints of achieving 40% reduction in tumor size and 50% reduction in PRL and secondary endpoints of radiologic stabilization and/or reduction and PRL normalization. Mean ErbB receptor protein expression will be compared between responders to lapatinib and non-responders by immunohistochemistry in pituitary tumor samples of these subjects collected from prior surgeries.
Sandostatin LAR Depot vs. Surgery for Treating Acromegaly
AcromegalyPituitary NeoplasmThe purpose of this study is to compare the efficacy of Sandostatin LAR® (Registered Trademark) Depot to transsphenoidal surgery in previously untreated acromegalic patients with macroadenomas. The primary goal is to normalize insulin-like growth factor-1 (IGF-1) levels. Secondary goals are to compare Sandostatin LAR® (Registered Trademark) Depot treatment and transsphenoidal surgery to achieve the following goals: suppress growth hormone levels to less than or equal to 2.5 ng/mL, relieve the clinical signs and symptoms of acromegaly, reduce the size of the macroadenomas, produce few side effects, assess the prognostic value of baseline pituitary adenoma size, extension and baseline growth hormone level on post-treatment growth hormone and IGF-1 levels, and assess the resource utilization of each treatment type.
Intraoperative Imaging of Pituitary Adenomas by OTL
NeoplasmsPituitary NeoplasmsThe primary end-point of the study is to determine the specificity and sensitivity of OTL38 in identifying pituitary adenomas when excited by an imaging probe. The investigators intend to enroll 50 patients in this study. The study is focusing on patients presenting with suspected pituitary adenomas who are considered to be good surgical candidates.
Response to Cabergoline and Pasireotide in Non-functioning Pituitary Adenomas and Resistant Prolactinomas...
Non-functioning Pituitary AdenomasProlactinomasThere are no available medical treatment options for patients with non-functioning pituitary adenomas (NFPA) or with resistant prolactinomas to dopamine agonists (DA) who are not cured by surgery. The study of the receptors by quantitative messenger ribonucleic acid (mRNA) expression levels and immunohistochemistry analysis might end with a better understanding of these tumors. Besides that, it will be assessed the in vitro and in vivo responses to pasireotide (for NFPA and prolactinomas) and cabergoline (for NFPA). These responses will be compared with the receptor expressions which may be a tool as a predicting element of the response to these compounds.
Effects Exercise Training in Patients With Pituitary Adenoma
Pituitary AdenomaThis study planned to investigate the effects of aerobic training combined with strengthening training and yoga on biochemical factors, physical performance and quality of life in people with pituitary adenoma. The hypotheses are; H1: Aerobic training combined with strengthening training is effective on biochemical factors in people with pituitary adenoma. H2: Aerobic training combined with strengthening training is effective on physical performance in people with pituitary adenoma. H3: Aerobic training combined with strengthening training is effective on quality of life in people with pituitary adenoma. H4: Yoga is effective on biochemical factors in people with pituitary adenoma. H5: Yoga is effective on physical performance in people with pituitary adenoma. H6: Yoga is effective on quality of life in people with pituitary adenoma. H7: Aerobic training combined with strengthening training and yoga is effective on biochemical factors, physical performance and quality of life in people with pituitary adenoma.
Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor
Cushing's DiseaseCorticotroph AdenomaThis study was designed to check the efficacy of a new oral medical drug treatment, namely Cabergoline, for the treatment of Cushing Disease due to pituitary adenoma. Background: Cabergoline is a Dopamine 2 receptor agonist. Corticotroph adenoma has shown to have the D2 receptor in in vitro studies.
Transsphenoidal Extent of Resection Study
Pituitary AdenomaThe purpose of this research study is to compare the extent of resection (EOR) in patients with nonfunctioning pituitary adenomas undergoing transsphenoidal surgery using a microsurgical technique to those patients who have undergone surgery with a fully endoscopic technique. Another goal is to compare surgical complications, endocrine outcomes, visual outcomes, length of surgery, length of hospital stay, and readmission rates between the two transsphenoidal surgery techniques. This is an observational data collection study with no experimental procedures or experimental medicines. Endonasal transsphenoidal removal of a pituitary tumor is a unique procedure and there is little information comparing the two surgical techniques.