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 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 evaluating the diagnostic value of a new protein-specific probe called 18F-T2 in PET/CT 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, PET/CT imaging will be performed to capture detailed images of the tumors. Within one week, participants will also undergo a whole-body PET/CT 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 PET/CT 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.

Researchers are evaluating the use of Gallium-68-DOTATATE PET/MRI 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 investigating a gene transfer therapy using a patient's own white blood cells genetically engineered to attack specific mutations in metastatic solid cancers that have not responded to standard treatments. This Phase II study aims to determine if these modified cells, alone or combined with pembrolizumab, can shrink tumors in patients with various cancers including gastrointestinal, genitourinary, breast, ovarian, non-small cell lung cancer, endocrine tumors, neuroendocrine tumors, and multiple myeloma with solid masses. Participants receive a preparative regimen involving cyclophosphamide and fludarabine to prepare the body, followed by an infusion of their own T-cells modified to express T-cell receptors targeting their tumor's neoantigens. Some participants also receive pembrolizumab before and after cell infusion. Treatment includes high- or low-dose aldesleukin to support the infused cells. The study involves hospitalization for treatment and recovery, followed by long-term antibiotic and possible antiviral therapy. During the study, participants undergo extensive screening, including tumor biopsies, scans, blood tests, and physical exams. After treatment, researchers monitor tumor response with imaging and clinical assessments at multiple time points up to two years. Safety and tolerance are also evaluated. Participants are followed closely with regular visits to assess treatment effects, manage side effects, and track disease status.

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.

Researchers are studying the accumulation and distribution of an investigational tracer called [68Ga] Ga-FAPI-04 in patients with high-grade neuroendocrine cancer. This early phase I trial aims to determine where and how much this tracer collects in both normal and cancerous tissues using advanced imaging techniques. The study utilizes PET/CT scans, where PET detects the radioactive tracer and CT provides detailed images of organs and any inflammation. Participants will receive an intravenous injection of [68Ga] Ga-FAPI-04, followed by a PET/CT scan approximately one hour later lasting about 25 minutes. The trial focuses on exploring the tracer's biodistribution, pharmacokinetics, and retention in tumors to assess its potential for clinical diagnostic performance. This is a single intervention study without masking or blinding. During the study, participants will undergo PET and CT scans to evaluate tracer uptake and distribution. Researchers will measure biodistribution, pharmacokinetics, tumor tissue concentrations, and standardized uptake values on the day of the scan. The total participation involves preparation for and completion of the scan and monitoring on the same day. Safety and diagnostic data will be collected to understand how this imaging agent behaves in the body.