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Pituitary Diseases clinical trials

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NCT ID: NCT05338125 Terminated - Pituitary Adenoma Clinical Trials

Electrophysiology of the Human Pituitary Gland

Start date: December 10, 2020
Phase: N/A
Study type: Interventional

Measurment of electrophysiological properties of the human pituitary gland during removal of a pituitary adenoma. Assessment if these properties are sufficient for intra-operative identification of different tissues.

NCT ID: NCT04106531 Terminated - Pituitary Tumor Clinical Trials

Validation of a Quality of Life Metric "Prolac-10"

Prolac-10
Start date: October 15, 2019
Phase:
Study type: Observational

This is a short-term validation study of a quality of life metric "Prolac-10" for patients diagnosed with a prolactinoma, undergoing new medical therapy.

NCT ID: NCT03930771 Terminated - Clinical trials for Recurrent Pituitary Adenomas

Capecitabine and Temozolomide for Treatment of Recurrent Pituitary Adenomas

TMZ-Cap
Start date: May 21, 2019
Phase: Phase 2
Study type: Interventional

This is an open label study to assess the efficacy of capecitabine (CAP) and temozolomide (TMZ) in recurrent pituitary adenomas. There will be a safety run-in of at least three patients to establish any dose limiting toxicities. Enrolled patients will receive treatment in 28-day cycles: capecitabine 1500mg/m2 per day (divided into two doses with maximum daily dose of 2500mg) on days 1 through 14 and oral temozolomide 150 to 200 mg/m2 on days 10 through 14. This will be followed by 14 days off treatment. MRI imaging will be completed after every two cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

NCT ID: NCT03515603 Terminated - Pituitary Adenoma Clinical Trials

Endocrine Outcome of Surgery for Pituitary Adenoma

Start date: May 10, 2018
Phase: N/A
Study type: Interventional

Prospective and randomized compare between microsurgical and endoscopic transsphenoidal MRI assisted resection of pituitary adenomas.

NCT ID: NCT02749227 Terminated - Pituitary Tumor Clinical Trials

Pasireotide LAR Therapy of Silent Corticotroph Pituitary Tumors

PASSILCORT
Start date: July 10, 2017
Phase: Phase 2
Study type: Interventional

This is a phase II, open-label, 12-month pilot study in 10 patients with silent corticotroph pituitary tumors testing the hypotheses that Pasireotide long-acting release (LAR) treatment of patients with silent corticotroph pituitary tumors and elevated plasma Proopiomelanocortin (POMC) levels will reduce plasma POMC levels and this will be associated with a reduction in pituitary tumor size. Pasireotide LAR 40 mg will be administered monthly. Baseline and monthly visits on therapy will monitor plasma levels of POMC, other pituitary function, safety labs, glucose tolerance, physical examination, and visual fields. Pituitary magnetic resonance imaging (MRI) will be done at baseline, 6 months and 12 months of therapy. The eligible patient population will consist of adult patients with known silent corticotroph pituitary tumors and elevated plasma levels of POMC.

NCT ID: NCT02743442 Terminated - Pituitary Neoplasms Clinical Trials

Da Vinci Transoral Robotic-assisted Surgery of Pituitary Gland

ROBOPHYSE
Start date: March 2016
Phase: N/A
Study type: Interventional

Over the past 30 years, endoscopic transnasal techniques have gained a major interest, and anatomic limits have been widened in order to extend neurosurgical applications. For many years, robotic-assisted surgery using the da Vinci system (Intuitive Surgical Inc, Sunnyvale, California, USA) has been greatly developed, especially in urology and gynecology. Robotic-assisted surgery has been performed for pharyngeal and laryngeal cancers in a minimally invasive perspective. A robot-assisted preliminary series demonstrated the ability to approach the sella via oral approach without traumatic injury of nasal or oral cavity. Transoral approach avoids the complications of the endonasal resection: synechia, rhinitis sicca anterior, primary and secondary atrophican rhinitis, and empty nose syndrome. The investigators recently published a cadaveric study of transoral robotic-assisted skull base surgery to approach the sella turcica (Neurosurgical Rev. 2014; 37:609-17). In this study, the investigators will propose a new minimally invasive technique of pituitary surgery by transoral approach assisted by the da Vinci robot in patients with pituitary adenoma.

NCT ID: NCT02629549 Terminated - Neoplasms Clinical Trials

Intraoperative Imaging of Pituitary Adenomas by OTL

Start date: October 2015
Phase: Phase 1
Study type: Interventional

The 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.

NCT ID: NCT02419664 Terminated - Pituitary Tumours Clinical Trials

Ga-68-DOTATOC -PET in the Management of Pituitary Tumours

Start date: January 2015
Phase: Phase 3
Study type: Interventional

Title: Gallium (GA) -68-DOTATOC -PET (positron emission tomography) in the management of pituitary tumours Medical product: Ga-68-DOTATOC in PET/computer tomography (CT) Route of administration: Intravenously Diseases of interest: Pituitary tumours Aim: To study the detection of pituitary tumours with Ga-68-DOTATOC -PET (Ga-PET) and to correlate the tracer expression to somatostatin receptor (sst) occurrence Study design: Prospective non-randomised case-control study with open design with GA-PET before and after pituitary surgery in patients with pituitary tumours Study population: patients with acromegaly (n=10), Cushing's' disease of pituitary origin (n=10), TSH (thyreotropin) producing tumours (TSHomas) (n=5) and non-functioning pituitary adenomas (NFPA) (n=20) Number of patients: 45 Inclusion criteria: Adult man or woman (over 18 years) and naïve, unoperated pituitary tumour with growth hormone (GH) or adrenocorticotrophic hormone (ACTH)) or TSH production or NFPA without treatment with somatostatin analogues (SSA) or dopamine agonists. Exclusion criteria: Patient who may not attend to the protocol according to the investigators opinion. Pregnancy or lactating. Isolated prolactin producing tumours. Overproduction of gonadotropins. Carcinoids ie ectopic corticotrophin realising factor (CRF) production. Known or suspected allergy to the trial product or related products. Controls: Adult patients with Thyroid associated ophthalmopathy (TAO) before iv steroid infusion (part of another study see this protocol)- Study variables: Tumour detection, Tracer uptake as Standardised uptake value (SUV) max (SUVmax), SUV hotspot and SUV mean in regions of interests (ROIs) Time schedule: Recruitment of patients 2015-2017. Study termination 3 years later

NCT ID: NCT02396810 Terminated - Clinical trials for Pituitary Macroadenoma

Utilization of iMRI for Transsphenoidal Resection of Pituitary Macroadenomas

Start date: May 19, 2015
Phase: N/A
Study type: Interventional

The investigators are studying the utility of intra-operative magnetic resonance imaging (iMRI) during transsphenoidal pituitary surgery for large macroadenomas by randomizing patients to either an intra-operative MRI after resection, or no intra-operative MRI. The investigators will then count the number of gross total resection in each group of patients and also the complications related to surgery.

NCT ID: NCT01675037 Terminated - Clinical trials for Obstructive Hydrocephalus

Hypothalamic-pituitary Effects After Endoscopic Third Ventriculostomy

Start date: July 2012
Phase: N/A
Study type: Observational

Background: Endoscopic third ventriculostomy (ETV) is a standard procedure for the treatment of obstructive hydrocephalus in children and adults. Perforation of the third ventricle floor which is part of the hypothalamic-pituitary neuronal network is the key of this surgical procedure. Purpose: There are no prospective data available about the endocrine effects after ETV in children and adults. The principal aim of this prospective study is to evaluate the variability of hypothalamic-pituitary hormones and clinical effects in children and adults after ETV in order to plan a multicentric study.