Adrenal Gland Disorder

This trial studies neuroendocrine tumors, paraganglioma, pheochromocytoma, and other SSTR-positive tumors that are not currently approved for lutetium therapy called LUTATHERA. It aims to evaluate the effectiveness and safety of a similar treatment called lutetium (177Lu) edotreotide or 177Lu-DOTATOC in patients who have these diseases but are outside the standard indications for LUTATHERA. The study focuses on expanding knowledge about this therapy's role in controlling disease and managing side effects. Participants receive treatment with 177Lu-DOTATOC given by slow intravenous infusion over 30 minutes using a pump system. The dose depends on patient risk factors: those with fewer than two risk factors receive 7.4 GBq per cycle, while those with two or more risk factors receive 5.5 GBq per cycle. Each participant will receive 4 cycles of treatment. Risk factors include kidney impairment, previous toxicities, uncontrolled diabetes or hypertension, prior therapies, and disease burden. During the study, participants will have regular assessments over several months, including scans to measure disease control at 32 months and ongoing monitoring up to 44 months for progression-free survival, overall survival, safety, and quality of life. Researchers will check blood tests, organ function, and side effects. This non-randomized phase 2 study allows patients with measurable or evaluable disease and progressive tumors confirmed by imaging to be included, with follow-up to evaluate response and safety.

This research aims to evaluate how well 18F-metafluorobenzylguanidine (18F-MFBG) PET imaging detects and measures tumor burden in patients with pheochromocytoma, a type of tumor that highly expresses the norepinephrine transporter (NET). The study addresses limitations of current imaging methods, such as low resolution and long procedure times, by assessing a newer tracer that may provide better image quality and faster results. Patients with suspected or confirmed pheochromocytoma will receive a single intravenous injection of 18F-MFBG at a dose of 5.55 MBq/kg. After 60 minutes, participants will undergo a PET/CT or PET/MR scan to visualize the tumors. This imaging method allows for scanning shortly after injection without special preparation, potentially improving diagnostic processes. During the study, researchers will evaluate the safety of 18F-MFBG, the quality of the images, and how accurately the scans correspond to pathological diagnosis and treatment effects. They will monitor false positive and false negative results over about one year. Participants will be assessed through imaging and clinical follow-up, contributing to understanding the tracer's diagnostic value in pheochromocytoma.

Researchers are studying the use of 18F-metafluorobenzylguanidine (18F-MFBG) positron emission tomography (PET) to evaluate neuroendocrine tumors, mainly pheochromocytoma, paraganglioma (PPGL), and neuroblastoma (NB). These tumors express norepinephrine transporter (NET), which is targeted by imaging substances like 123I/131I-MIBG. However, current imaging methods have limitations such as low resolution and long waiting times, which affect diagnosis. This study aims to assess the safety, image quality, diagnostic accuracy, and tumor burden detection of 18F-MFBG PET in these neural crest tumors.

Researchers are studying adrenal tumor removal surgeries using a high-definition 3D laparoscopic system to improve outcomes compared to traditional 2D laparoscopy. This observational study explores the benefits of using 3D imaging, which offers better depth perception and spatial orientation, potentially reducing errors, fatigue, and operating time during adrenalectomies. The study focuses on both benign and malignant adrenal tumors. The surgery uses a 3D laparoscopic system where all operating room personnel wear polarized glasses to see stereoscopic images. Dissection is performed with a hybrid energy device called Thunderbeat. The study observes patients who underwent unilateral 3D laparoscopic adrenalectomy between 2013 and 2033, without comparing to other surgical approaches. Participants have their surgical outcomes monitored up to 30 days after surgery, including complication rates and length of hospital stay. Researchers also evaluate factors like bleeding, operative time, use of drainage, and differences in morbidity related to obesity, previous surgeries, patient age, anesthesia risk scores, tumor size, diagnosis, and tumor side. The study collects detailed data to understand how 3D laparoscopy affects adrenalectomy results over time.

Researchers are evaluating the accuracy of two diagnostic methods, 68Ga-Pentixafor PET/CT and adrenal venous sampling (AVS), in identifying the subtype of primary aldosteronism (PA) concurrent with autonomous cortisol secretion (ACS) in patients with adrenal nodules. This prospective, multicenter, randomized crossover trial aims to compare the diagnostic performance of these methods based on biochemical and clinical remission outcomes, focusing on whether 68Ga-Pentixafor PET/CT is not less accurate than AVS. The main goal is to guide treatment decisions effectively based on these diagnostic results. Participants are randomly assigned to one of two groups: one group undergoes 68Ga-Pentixafor PET/CT first followed by AVS, and the other group undergoes AVS first followed by 68Ga-Pentixafor PET/CT. Treatment strategies are then guided by the diagnostic findings. Both interventions are diagnostic tests used to determine unilateral primary aldosteronism, with specific criteria for diagnosis based on imaging and sampling results. This crossover design allows each patient to receive both diagnostic methods in different orders. During the study, participants will be monitored with a primary focus on the proportion of complete biochemical remission at 6 months postoperatively. Additional assessments include clinical remission rates and diagnostic accuracy in the surgical population. The study includes follow-up visits at 6 months after treatment to evaluate outcomes. Safety and treatment effectiveness are monitored throughout the trial, which is expected to last until the end of 2029.

Researchers are studying patients with endogenous Cushing syndrome to understand how often adrenal insufficiency occurs when treated with osilodrostat combined with glucocorticoid replacement. The study also examines new steroid biomarkers to monitor osilodrostat dosing, and assesses treatment durability, safety, and clinical improvement. This observational study aims to provide important insights into managing this condition with a block-and-replace approach. The study has two phases. In Phase 1 (Titration), participants start with a low dose of osilodrostat and add methylprednisolone replacement. Doses are adjusted to reach specific cortisol level goals, with frequent monitoring and communication. Once these goals are met, participants enter Phase 2 (Maintenance), where they continue treatment for 48 weeks with periodic cortisol tests to track treatment effects. Participants will regularly provide blood and saliva samples for cortisol and steroid profiling, and report symptoms related to adrenal insufficiency. Researchers will track clinical measures such as blood pressure, weight, and quality of life over about 48 weeks. The main outcome is the percentage of participants experiencing adrenal insufficiency during Phase 1, along with various secondary health and hormone measures throughout the study.

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, effectiveness, how the body processes, and the effects of atumelnant treatment in children with classic congenital adrenal hyperplasia (CAH). This Phase 2/3 study includes an open-label extension and involves pediatric participants aged 1 to under 18 years. The study is designed to assess these factors through multiple parts, including initial open-label cohorts, a randomized placebo-controlled phase, and a long-term extension. The study has three parts: Part A includes open-label, semi-sequential cohorts for different age groups with safety reviews before progressing; Part B is a double-blind, randomized, placebo-controlled phase comparing atumelnant to placebo; Part C is an open-label extension where participants from Parts A and B can continue treatment. Atumelnant and placebo are given as once-daily oral tablets with dosing based on weight. Participants will undergo various assessments including measuring morning serum androstenedione and 17-hydroxyprogesterone levels, pharmacokinetic and pharmacodynamic studies, and monitoring glucocorticoid doses. Safety and efficacy are evaluated at multiple time points up to 260 weeks. The study also includes long-term monitoring of hormone levels and glucocorticoid dosing while tracking participant adherence and health status throughout the study duration.

Researchers are evaluating the effects of atumelnant in adults with classic Congenital Adrenal Hyperplasia (CAH) due to 21-hydroxylase deficiency. This Phase 3, global, multicenter, randomized, double-blind, placebo-controlled study aims to assess the drug's efficacy, safety, pharmacokinetics, and pharmacodynamics in participants aged 18 to under 75 years who have been on stable glucocorticoid therapy for at least two months. Participants will be randomly assigned in a 2:1 ratio to receive either atumelnant 80 mg once daily or a matching placebo for 32 weeks. There is an option to increase the atumelnant dose to 120 mg daily at Week 20. Before treatment begins, a screening period of 3 to 6 weeks will determine eligibility. Approximately 150 participants may take part in this study. During the study, participants will be monitored for hormone levels related to CAH and glucocorticoid dosing, with primary outcomes measured at Week 32. Assessments include morning serum androstenedione levels and other hormone markers. Safety and adherence to study procedures will also be closely observed. The study period extends up to 32 weeks of treatment following screening, with detailed evaluations throughout.

Researchers are evaluating CRN04894, an adrenocorticotropic hormone (ACTH) receptor antagonist, in adults with ACTH-dependent Cushing's syndrome, including Cushing's disease and Ectopic ACTH Syndrome (EAS). This Phase 1b/2a 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 drug's 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.