Prolactinoma

This research evaluates a new fluorescent localization needle designed to improve the accuracy of pathological diagnosis for small breast duct micro lesions. These tiny lesions are difficult to locate precisely with current methods, risking missed diagnoses and additional surgeries. The study compares this novel device with traditional localization techniques in patients diagnosed with intraductal breast lesions who have undergone ductal excision. Participants in this retrospective study received breast ductal excision surgery using either the novel fluorescent localization needle featuring a controllable shedding quantum dot chiral nanofluorescent coating or conventional localization needles without coatings. Tissue samples from both groups were analyzed intraoperatively with frozen section analysis and postoperatively using paraffin-embedded pathological evaluation to assess diagnostic consistency. During the study, researchers analyze the concordance between intraoperative and postoperative pathological assessments to determine the clinical utility of the new fluorescent needle. The main outcome measured is the rate of agreement in pathological findings between the two sampling times. The study period covers data analysis from June to December 2025, with the overall study completion expected by May 2026. Participants are female patients aged 18 to 75 diagnosed by ductoscopy and treated with ductal excision.

This study focuses on women with breast duct lesions, including mammary tumors, nipple discharge, and breast ductal carcinoma in situ. It evaluates a new fluorescent localization needle designed with a controllable shedding quantum dot chiral nanofluorescent coating. The goal is to compare this novel device to traditional localization methods in order to improve the accuracy of pathological diagnosis for very small breast duct microlesions, which are difficult to locate precisely during surgery and pathology assessments. Participants undergo breast duct excision surgery using either the new fluorescent localization needle or a conventional localization needle without coating. This prospective, multicenter study compares how reliably rapid pathology during surgery matches postoperative pathology when using these two localization techniques. The study aims to assess if the new needle can help surgeons and pathologists better identify tiny lesions, potentially reducing missed diagnoses and additional surgeries. During the study, participants receive surgery with one of the two localization methods and have pathological assessments performed both intraoperatively and postoperatively over a 6-week period. Researchers measure how well the rapid pathology results align with the final postoperative diagnosis. The study spans from enrollment through 6 weeks after treatment, with ongoing monitoring to evaluate the clinical usefulness of the fluorescent needle. Participation involves consenting to surgery and follow-up assessments to track diagnostic agreement and outcomes.

Researchers are evaluating pasireotide as a treatment for people with prolactinoma who cannot use dopamine agonist therapy. The study aims to assess whether pasireotide is effective and safe for these patients, focusing on those with intolerance, contraindications, or resistance to dopamine agonists. This is a Phase 2 interventional study sponsored by Memorial Sloan Kettering Cancer Center. All participants will begin open-label treatment with pasireotide long-acting release LAR, starting with a 40 mg intramuscular dose in the first week. If tolerated, the dose will be increased to 60 mg every 4 weeks, with adjustments based on response and tolerability as judged by the investigator. Patients will return to the study center every 28 days - 7 days for medication administration and evaluation. Participants will be monitored through blood tests, tumor measurements, and patient questionnaires at baseline, week 12, 24, and 28. Researchers will track biochemical response within 24 weeks to measure treatment effect and radiographic response during the same period. Safety and tolerability assessments will be ongoing, and patients may continue treatment and follow-up as per study protocol until February 2027.

Researchers are evaluating a new, less invasive laboratory test to analyze DNA from nipple fluid in adults with spontaneous, single-duct, unilateral bloody or blood-tinged nipple discharge. The goal is to distinguish between benign and malignant causes of the discharge and potentially reduce unnecessary surgeries. This observational study enrolls about 30 participants who are already scheduled for standard diagnostic breast surgery at a single center. Before surgery, a small sample of nipple fluid or nipple aspirate fluid is collected along with a blood sample. The DNA in the fluid is analyzed using low-pass whole-genome sequencing and genome-wide DNA methylation profiling. These data are compared to surgical pathology results to develop a model that classifies lesions as benign or malignant. Participants receive usual care, and study results do not affect their treatment. There is no long-term follow-up required. During the study, participants undergo sample collection before surgery and standard surgical procedures. Researchers review surgical pathology reports to assess the tests accuracy, including sensitivity, specificity, and predictive values. Safety monitoring includes minimizing discomfort from fluid collection and blood draws. The total participation time covers preoperative sampling through receipt of final pathology, with technical success and sample adequacy also assessed.

Researchers are studying pituitary tumors, which are a varied group of tumors affecting the pituitary gland. This observational study focuses on collecting detailed clinical, biochemical, morphological, and pathological data from over 1600 patients who have undergone neurosurgical removal of pituitary tumors in the past 20 years. The goal is to develop a prognostic classification to better predict tumor behavior and outcomes, as current data on epidemiology and prognosis are inconclusive. The study involves patients who have had surgery for pituitary tumors, with data collected retrospectively and prospectively. The main focus is on monitoring the frequency of disease recurrence. Participants have been followed for at least two years after their tumor removal, allowing researchers to track tumor recurrence over time. Participants will be observed from enrollment through 24 months of follow-up to assess tumor recurrence. Researchers will gather information from medical records and follow-up visits to evaluate outcomes. This study does not involve any experimental treatment, but rather monitors surgical outcomes and tumor behavior to improve future understanding of pituitary tumors.

Researchers are studying tumors of the hypothalamic-pituitary unit in children and adults aged 2 to 70 years, aiming to understand the genetic causes and developmental pathways involved in pituitary gland tumors. This observational study also serves as a training protocol for fellows and students to learn about genetic defects, tumor recognition, management, and complications. The study includes research on new MRI tools and psychological effects of cortisol secretion in pediatric patients with Cushing disease. Participants with tumors or related hypothalamic-pituitary disorders undergo various procedures including MRI scans and tissue specimen collection. The study collects peripheral blood samples and tumor tissues for molecular genetic testing and whole exome sequencing. It also evaluates cognitive, psychological, and patient-reported outcomes related to hypercortisolemia and adrenal insufficiency in children with Cushing syndrome. Participants are assessed through imaging studies, biochemical tests, and genetic analysis. The study monitors psychological and cognitive health and collects patient-reported data on mental and social well-being. This protocol also functions as a screening platform for future clinical studies on diagnosis, treatment, and follow-up of pituitary tumors. Participation involves ongoing evaluation with no specified end date, supporting the development of new therapeutic approaches and research in pituitary tumor biology.

This research aims to validate the B-COMPASS, a computational model developed by the BEAMER project to improve patient adherence to treatment across various diseases. Adherence to treatment is a widespread issue leading to increased healthcare use and premature death, with about half of medications not taken as prescribed. The study evaluates the models ability to predict adherence, identify patient support needs, and enhance healthcare engagement in six therapeutic areas, including cardiovascular, endocrinology, immunology, neurology, oncology, and rare diseases. Participants complete the BEAMER questionnaire, which the B-COMPASS uses to group patients based on their adherence needs and predict their adherence. Patients are randomized into a control group receiving standard care or an intervention group receiving enhanced engagement through educational materials for healthcare providers tailored to the patients B-COMPASS profile. Engagement occurs in person or by phone, depending on patient schedules, and healthcare providers may also be randomized to limit knowledge of the B-COMPASS in control groups. Participants are involved in two main data collections spaced from 2 weeks to 6 months apart, during which adherence measures, patient support needs, and perceptions of engagement are assessed. The study measures the accuracy, validity, and reliability of B-COMPASS predictions, its impact on adherence, patient and provider perceptions, and cost-effectiveness. The total participation timeline varies by site and disease area, with continuous monitoring of healthcare utilization and patient experience.

Researchers are studying patients with pituitary complex and rare diseases to better understand their clinical features and outcomes. This observational study at Peking Union Medical College Hospital aims to identify factors influencing remission rates, associated comorbidities, perioperative events, radiological findings, and pathological characteristics. By comparing different patient groups, the study seeks to improve knowledge about managing and predicting the course of these conditions. Participants include patients diagnosed with various pituitary disorders such as pituitary adenomas, craniopharyngiomas, Rathkes cleft cysts, sellar region germ cell tumors, and cavernous sinus syndrome. Those needing surgical removal or biopsy of pituitary pathologies will undergo transsphenoidal surgery or craniotomy. Treatments studied involve surgical removal and biopsy procedures to collect tissue for examination and diagnosis. During the study, participants will have detailed clinical evaluations, provide comprehensive medical histories including symptoms, treatments, and outcomes, and take part in follow-up assessments to monitor disease progression. Researchers will track remission starting one week after surgery and continuing up to three years, along with comorbidities and postoperative complications over the same period. The study collects imaging and pathological data to enhance understanding of these rare diseases.

Researchers are conducting an observational, longitudinal study focused on patients with pituitary disorders who are followed at the Unit of Endocrinology of Azienda Ospedaliero-Universitaria of Modena. The study is designed to collect detailed clinical and epidemiological data to better understand this patient population over time. It includes both a retrospective phase and a prospective phase to capture comprehensive patient information. The study has two phases the first phase involves retrospectively registering all patients with pituitary disorders treated at the center. The second phase prospectively enrolls patients attending the Unit of Endocrinology to gather ongoing data. Patients personal information, details about their pituitary disease, symptoms, physical exams, imaging results, visual field data, and treatments including surgeries, hormone tests, and therapies will be collected and stored in an anonymized database. Participants will be involved through data collection from their medical records and ongoing clinical visits. Researchers will assess various clinical measures such as radiological imaging, hormone levels, and therapy management. The main outcome is to characterize pituitary patients over a 10-year period, along with studying their management. The study is expected to continue monitoring patients throughout this time frame to gain insights into pituitary disease progression and treatment.

Neuroendocrine neoplasms NENs are a diverse group of tumors that arise from hormone-producing cells and can develop in various organs. Their behavior ranges from benign to aggressive, sometimes causing serious health problems due to excess hormone production. Many NENs are inherited or part of genetic syndromes, while others arise from non-inherited genetic changes. This research aims to identify genetic defects causing NENs in a large group of Mexican patients, improving understanding of their molecular causes and potential treatment targets. This study collects blood and tissue samples from adult patients with different types of NENs at two hospitals in Mexico City. Participants undergo genetic testing using three methods targeted gene sequencing, analysis of gene copy number changes, and full exome sequencing in selected cases. The study also gathers detailed clinical, laboratory, imaging, and pathology information, and offers genetic screening to family members when appropriate. Samples and data are carefully stored and analyzed to detect genetic variants associated with NENs. Participants provide blood and, when possible, tumor tissue samples for DNA analysis. Researchers collect clinical and family history data, along with laboratory and imaging results. The main outcome is identifying genetic defects linked to NENs over a follow-up period of up to 15 years. Participants who want to know their genetic results receive detailed reports. The study seeks to correlate genetic findings with clinical features and outcomes, aiming to discover new genetic associations and improve future diagnosis and treatment strategies.