Pituitary Disorder

Researchers are evaluating the use of Gallium-68-DOTATATE PETMRI in patients with somatostatin receptor-positive SSTR-positive central nervous system CNS tumors, mainly focusing on meningioma but also including other tumor types such as esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma, and SSTR-positive systemic cancers metastatic to the brain. The study aims to assess the diagnostic usefulness of this imaging technique, especially in distinguishing tumor recurrence from post-treatment changes, with a particular interest in cases where tumor location limits surgical removal or where patients have higher-grade disease or previous radiation treatment. This is a Phase 4 interventional study sponsored by Weill Medical College of Cornell University.

There is no clear agreement on the best way to treat cystic lesions in the pituitary and surrounding areas, which are rare and challenging to manage. Traditional treatments like surgery or radiation often cannot fully remove or treat the cyst wall without serious risks. This research evaluates the use of stereotactic intracavitary instillation of 90yttrium colloid as a possible treatment option for these cystic sellar and parasellar tumors, aiming to find a safer and effective approach. The experimental treatment involves inserting 90yttrium colloid directly into the cystic cavity of the tumor during surgery. The neurosurgeon will decide the specific surgical approach based on individual patient needs, which will be described in the surgical consent. This procedure is compared to standard surgical care, and patients are monitored closely after treatment. Participants will undergo surgery as part of standard care, followed by monitoring for cyst shrinkage at 12 months after treatment. Imaging with PET-CT will be used within three weeks of treatment to locate the 90yttrium colloid. Researchers will track clinical and radiological stability, neurological function, and tumor response throughout the study, which may last several years until 2031.

Researchers are evaluating the safety and tolerability of GenSci134, a drug given by subcutaneous injection, in healthy adult volunteers and adults with Growth Hormone Deficiency AGHD. This study has two parts the first part involves healthy volunteers in two phasessingle and multiple ascending dosesand the second part includes AGHD patients receiving a single ascending dose. The trial aims to assess safety, how the drug acts in the body pharmacokinetics and pharmacodynamics, immune responses, and other exploratory effects. In the first part, Phase Ia tests single doses of GenSci134 in healthy adult males across seven dose groups with placebo and active controls. Phase Ib evaluates multiple doses in healthy adult males and females in three dose groups. The second part, Phase Ic, studies two dose groups of AGHD patients receiving single doses of GenSci134 compared to active controls. The active comparator is recombinant human growth hormone injection given daily for 28 days. Treatments are given subcutaneously, and the study is randomized and double-blind. Participants will undergo safety assessments including monitoring adverse events for up to three months after dosing. Researchers will collect data on drug absorption, effects on the body, immune response, and tolerability. Healthy volunteers and AGHD patients will be monitored through scheduled visits involving laboratory tests and evaluations to track any side effects and responses to the treatments. The total participation duration varies by study phase and dosing schedule.

Researchers are evaluating the long-term safety of lonapegsomatropin in children with growth hormone deficiency who are already being treated with this medication. This study is observational and aims to gather real-world safety data over time after the drug has been authorized for use. The focus is on monitoring potential risks such as the development of tumors and type 2 diabetes over a period of five years. Participants receive lonapegsomatropin, administered once weekly by subcutaneous injection as part of their usual care. The study does not involve additional interventions but observes patients who are already treated with this therapy. The observational period extends for at least five years to collect safety data and compare it with historical information from previous studies. During the study, researchers will monitor for the occurrence of benign and malignant tumors, type 2 diabetes, and other adverse events affecting the kidneys, liver, immune system, and nervous system. They will also track medication errors and measure the response of Insulin-like Growth Factor-1 IGF-1 to treatment. Participants are followed up regularly to collect this information, with the study lasting until March 2033.

This clinical trial investigates the safety and recovery benefits of tubeless laparoscopic adrenalectomy in patients undergoing adrenal gland removal surgery. The study aims to answer whether avoiding drainage tubes after surgery helps patients recover more quickly, focusing on pain, the time to first get out of bed, and the recovery of intestinal function. It is a prospective, single-center, randomized controlled study enrolling 200 patients who need laparoscopic adrenalectomy. Participants are randomly assigned to one of two groups one group receives surgery without drainage tubes tubeless group, and the other group has drainage tubes placed after surgery drainage group. The study compares outcomes such as pain scores, blood tests, and recovery indicators between these groups. Follow-up includes adrenal ultrasounds at one and six months post-surgery to monitor recovery and safety. During the study, participants will have blood tests and assessments of pain, time to mobilization, and intestinal function for the first three days after surgery. Researchers will also monitor for complications like fever and wound infections. Follow-up ultrasound exams at one and six months will help evaluate longer-term recovery. The trial uses block randomization and collects data to assess whether tubeless surgery promotes faster and safer recovery after adrenalectomy.

Researchers are evaluating the safety and effectiveness of a monthly Leuprorelin treatment given for 24 months in children diagnosed with central precocious puberty CPP. This phase 4, single-arm, open-label study focuses on children with early puberty signs, primarily girls younger than 9 years and boys younger than 10 years, who have reached Tanner stage 2 or higher. The study aims to understand how this treatment impacts hormone levels and puberty progression over two years. Participants will receive Leuprorelin injections every four weeks for up to 24 months. This treatment is designed to influence hormone levels by suppressing luteinizing hormone LH after stimulation with gonadotropin-releasing hormone GnRH. The study tracks changes in hormone levels, pubertal development, growth parameters like height and weight, and monitors for any treatment-related adverse events during this period. During the trial, children will undergo regular assessments including hormone tests to measure LH, follicle-stimulating hormone FSH, testosterone, and estradiol levels, as well as evaluations of their pubertal stage and growth. Safety is closely monitored by recording any side effects related to the treatment. The primary outcome is the suppression of peak LH levels 24 weeks after starting treatment, with ongoing follow-ups up to 96 weeks to observe longer-term effects and safety.

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 studying the effect of Debio 4126, a 12-week extended-release octreotide injection, in maintaining insulin-like growth factor 1 IGF-1 levels at or below the upper limit of normal in patients with acromegaly who have previously been treated with somatostatin analogs. This Phase 3 randomized trial compares Debio 4126 to a placebo during a double-blind period to evaluate its efficacy and safety. Participants in the double-blind period receive intramuscular injections of either Debio 4126 or placebo every 12 weeks for 36 weeks, totaling three injections. Those whose IGF-1 levels remain at or below the upper limit of normal at Week 34 may enter an open-label phase receiving Debio 4126 injections every 12 weeks for an additional 24 to 60 weeks. Rescue medication is allowed for participants whose acromegaly is not well controlled during specified times. Throughout the study, participants undergo evaluations of IGF-1 levels, growth hormone levels, and treatment tolerability, including assessments of injection site reactions and adverse events. The primary outcome is the percentage of participants with IGF-1 levels at or below the upper limit of normal at 36 weeks. Safety and efficacy measures continue for up to 108 weeks, with ongoing monitoring of medication levels and rescue treatment use.

Researchers are evaluating CRN04894, an adrenocorticotropic hormone ACTH receptor antagonist, in adults with ACTH-dependent Cushings syndrome, including Cushings disease and Ectopic ACTH Syndrome EAS. This Phase 1b2a open-label study aims to explore the safety, tolerability, pharmacokinetics PK, and pharmacodynamic biomarker responses of CRN04894 in this patient population. The study is a first-in-disease, multiple-ascending dose exploratory trial to better understand how the drug behaves and affects the condition. Participants will receive oral doses of atumelnant CRN04894 once daily for either 10 or 14 days in a sequential, open-label format. The treatment periods are followed by a 4-day washout phase after the 10-day dosing group. The study includes fixed-dose cohorts and monitors participants throughout these periods to assess the drugs impact on the disease and the body. During the study, participants will undergo monitoring for safety, including treatment-emergent adverse events, adrenal insufficiency, and laboratory test findings, all assessed up to Day 15. Pharmacokinetic measures include maximum plasma concentration, time to reach this concentration, and plasma exposure over time. Additionally, early morning serum cortisol levels will be tracked to evaluate changes from baseline. The total participation involves dosing and follow-up assessments to collect this comprehensive data.

This research aims to learn about the safety of Somatrogon, a long-acting growth hormone, for treating pediatric growth hormone deficiency p GHD in children aged 3 to 17 years in India. Pediatric GHD is a condition where the body produces too little growth hormone, leading to shorter height in affected children. The study focuses on participants confirmed with p GHD and prescribed Somatrogon injections. Participants will receive Somatrogon as part of their routine clinical care, and the study will observe their health over a period of up to three years. The safety will be monitored by tracking any side effects, expected or unexpected, that occur after taking Somatrogon. Follow-up will be conducted through clinic visits or phone calls, but regular clinic visits are not mandatory. During the study, researchers will collect information on adverse events and treatment adherence, including missed injections, over the three-year period. The goal is to understand the safety profile of Somatrogon in this patient group. Participants involvement includes providing informed consent, and assessments will be conducted as part of their usual care without additional interventions specifically for the study.