Pheochromocytoma

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 evaluating the diagnostic value of a new protein-specific probe called 18F-T2 in PETCT imaging for people with solid tumors that are likely to express high levels of CAIX protein. The study will also assess how safe and tolerable the 18F-T2 injection is, as well as measure its radiation dosage. This research is important to better understand how well 18F-T2 can detect these tumors compared to standard imaging techniques. Participants with tumors suspected to express high levels of CAIX will receive an intravenous injection of 18F-T2. About an hour after the injection, PETCT imaging will be performed to capture detailed images of the tumors. Within one week, participants will also undergo a whole-body PETCT scan using 18F-FDG, a commonly used imaging agent, to allow comparison between the two imaging methods. During the study, participants will be monitored for any adverse events within 24 hours after the 18F-T2 injection to evaluate safety and tolerability. Researchers will measure the diagnostic sensitivity and specificity of 18F-T2 PETCT for detecting CAIX-positive tumors. They will also assess uptake values in tumors on both 18F-T2 and 18F-FDG scans, analyze the correlation between 18F-T2 uptake and CAIX expression in tissue samples, and evaluate radiation dosimetry. The study will continue until one month after completion for outcome assessments.

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.

The trial investigates the treatment of postinduction hypotension, a common complication during emergency abdominal surgery caused by factors like sepsis and low blood volume. This condition can lead to serious organ damage, so preventing and managing it quickly is important. The study compares two doses of norepinephrine bolus5 mcg and 10 mcgto find the best approach for treating low blood pressure in this setting. Participants will be randomly assigned to receive either a 5 mcg or 10 mcg norepinephrine bolus if their mean arterial pressure drops below 65 mmHg during surgery. The drug is prepared by diluting norepinephrine to a concentration of 10 mcgmL, then further diluted for dosing. If blood pressure does not improve within 2 minutes, the bolus may be repeated up to three times, followed by an infusion if needed. Fluid status will be assessed using leg raising maneuvers and fluid boluses before surgery, and heart rate and blood pressure will be monitored every 2 minutes for 30 minutes after skin incision. During the study, participants will undergo close blood pressure and heart rate monitoring at specified intervals. Researchers will measure the success of managing hypotension from anesthesia induction until 30 minutes after surgery begins. They will also assess the time and extent of low blood pressure, episodes of slow heart rate, and high blood pressure. The entire participation period covers the time from anesthesia induction to 30 minutes post-incision, focusing on immediate treatment response and safety under surgical conditions.

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.

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 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.