Adrenal Cancer

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 therapys 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 MBqkg. After 60 minutes, participants will undergo a PETCT or PETMR 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 tracers 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 123I131I-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.

Neuroendocrine neoplasms NENs are rare cancers found in the gastrointestinal tract, pancreas, lungs, adrenal glands, and other body areas. These cancers often have a high risk of returning and a low chance of survival. This trial is a Phase I study to test a new drug called ADCT-701 in adults with NENs, malignant adrenocortical carcinoma ACC, or malignant peripheral nerve sheath tumors MPNST. The study aims to find the maximum tolerated dose of ADCT-701 and evaluate its safety and preliminary anti-tumor activity. Participants will receive ADCT-701 as an intravenous infusion once every 21 days in treatment cycles. The drug dose will be gradually increased to find the best dose while monitoring for side effects. During the first two cycles, participants will visit the clinic 10 times, with fewer visits in later cycles. Treatment may continue for up to two years. After treatment ends, follow-up visits will occur four times over four months, then every nine weeks, continuing for up to five years from the start of treatment. Throughout the study, participants will undergo physical exams, blood and urine tests, imaging scans, heart function tests, and activity assessments. A tumor biopsy may be required. Researchers will monitor participants health, treatment effects, and side effects closely. The primary outcome is determining the maximum tolerated dose during the first treatment cycle. Safety, drug effects, and immune responses will be tracked for up to five years.

Researchers are studying aggressive pituitary tumors through a national research registry called HYPOcare, which gathers patient information from a multidisciplinary consultation meeting. This meeting brings together experts from across the country to help guide patient care and collect one of the largest cohorts of patients with aggressive pituitary tumors both nationally and internationally. Currently, the data is used only for clinical management and not for research purposes. The study involves adult patients with pituitary tumors whose medical files have been reviewed by the HYPOcare consultation meeting. There is a single group of participants, and the study is observational, meaning no new treatments or interventions are given as part of the trial. The registry collects clinical data to support research on the characteristics of aggressive pituitary tumors. Participants provide their medical information for analysis, and researchers will study the aggressiveness of the tumors using transcriptome analysis over a three-year period. No experimental treatments are administered, and no direct patient visits or interventions are required as part of this observational research. The study aims to improve understanding and future management of aggressive pituitary tumors through data collection and analysis.

Researchers are studying gene transfer therapy using patients own white blood cells genetically engineered to target specific mutations in metastatic solid tumors. This Phase II trial aims to evaluate if these modified T-cells, alone or with pembrolizumab, can shrink tumors in adults whose cancers have not responded to standard treatments. The study includes participants with various metastatic cancers such as gastrointestinal, genitourinary, breast, ovarian, lung, endocrine tumors, and multiple myeloma with solid masses. Participants receive a preparative regimen of cyclophosphamide and fludarabine to reduce immune cells, followed by infusion of their genetically modified T-cells. Those in one group also receive pembrolizumab before and after the cell infusion. Aldesleukin is administered to support the survival of the infused cells. The treatment process includes leukapheresis to collect white blood cells, cell modification in the lab, hospital stays for infusions and recovery, and extended post-treatment drug regimens. Throughout the trial, participants undergo multiple assessments including scans, blood, urine, heart, and lung tests. Safety and tumor response are monitored over time, with primary outcomes measured at 6 and 12 weeks post-infusion and at regular intervals thereafter. Participants are followed for up to two years with ongoing evaluations and medication to prevent infections. The study may last several years, with long-term monitoring to assess treatment effects and safety.

Researchers are conducting a retrospective observational cohort study to evaluate clinical, pathological, and treatment data of people diagnosed with adrenocortical carcinoma since the year 2000. This rare cancer has a notably higher incidence in certain regions of Brazil, partly due to a common genetic mutation called TP53-R337H. The study aims to characterize this patient group and identify factors that influence outcomes, focusing on cases from major Brazilian treatment centers. Participants in this study are identified based on past clinical records rather than receiving new treatments. The study collects data from medical evaluations and follow-ups conducted at reference centers, including initial diagnosis and recurrences from 2000 onward. There are no interventions or experimental treatments given during this observational study. Participants involvement includes reviewing their medical history and clinical data over approximately 18 months. Researchers will analyze demographic and clinical characteristics from existing records to better understand the disease in this population. The study does not involve active treatment but focuses on data collection and analysis for improved knowledge of adrenocortical carcinoma in Brazil.

Researchers are investigating the causes and development of adrenal tumors, which include adrenocortical carcinoma, Cushing syndrome, Conn syndrome, and pheochromocytoma. The study aims to better understand how these tumors form and to evaluate new treatment options for patients with malignant adrenal tumors, addressing the limited current therapies available. This observational research is sponsored by the University of Wuerzburg and has been ongoing since 2002. Participants in the study may provide tumor material and related biological samples if they have adrenal tumors. Additionally, biological samples are collected from patients without adrenal tumors to serve as comparison controls. The research does not involve experimental treatments but focuses on collecting and analyzing biospecimens to explore tumor biology and potential therapies. Throughout the study, participants contribute by providing tumor and biosample materials. Researchers analyze these samples to study tumor characteristics and evaluate possible new treatments. There are no specific outcome measures listed. The study is observational, with no assigned treatments, and aims to gather information to support future therapeutic developments. Participants involvement duration varies, and the study is expected to continue until December 2032.

Researchers are evaluating the tissue-agnostic effectiveness of the anti-PD1 antibody nivolumab in patients with advanced or metastatic rare tumors that express PD-L1 with a combined positive score of 10 or higher. This phase II basket trial includes patients whose cancers have progressed despite standard treatments. Rare tumors, defined by low incidence rates, collectively represent a significant portion of cancers with generally poor prognosis and limited clinical trial representation. Participants receive intravenous nivolumab at a dose of 480 mg every 4 weeks, continuing until disease progression, limiting toxicity, or for up to 12 months if responses are stable or improving. After treatment ends or discontinuation, patients are followed by phone every 60 days until death. This innovative approach targets the molecular characteristic PD-L1 regardless of tumor origin, aiming to provide new therapeutic options across many rare cancer types. During the study, researchers assess tumor response using RECIST v1.1 criteria and monitor biomarkers including PD-L1 expression, circulating tumor DNA, and microvesicles to understand treatment effects. Patients undergo regular evaluations to measure objective response and progression-free survival. Safety is closely monitored throughout the treatment and follow-up periods. The study is conducted across multiple centers to overcome challenges in rare cancer research and is expected to last about four years.