Neuroendocrine Tumor (NET)

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.

Researchers are studying whether adjusting the dose of Lutetium-177 DOTATATE (Lutathera) based on individual dosimetry improves treatment results for adults with unresectable neuroendocrine tumors. This randomized controlled trial compares the standard fixed dose with a customized dosing approach guided by tumor and organ uptake, aiming to evaluate if personalized treatment can enhance outcomes. The study is sponsored by the University of Iowa and involves patients with well-differentiated gastroenteropancreatic neuroendocrine tumors. Participants will receive Lutathera through an intravenous infusion every 8 weeks for up to four cycles. The first dose is fixed at 200 millicuries for all participants. Those in the investigational group may receive higher doses (up to 400 millicuries) in subsequent cycles based on dosimetry imaging that tracks radiation exposure to tumors, kidneys, and bone marrow. The standard group continues with 200 millicuries per cycle. Imaging such as SPECT/CT scans and blood tests are performed to monitor the distribution and effects of the treatment. During the study, participants will undergo PET/CT scans before treatment, blood tests for several weeks after each Lutathera dose, and complete questionnaires about their health and symptoms. Follow-up visits occur about every 8 weeks during treatment and at 2, 3, 6, and 12 months after the last cycle. Long-term monitoring continues to assess side effects and treatment outcomes, including CT scans at 6 months and lifelong follow-up for radiation-related effects. The main outcome measure is the tumor response rate 6 months after treatment.

Researchers are studying a new treatment called 177Lu-TATE-RGD for patients with tumors that have high levels of SSTR2 and integrin αVβ3. This early-phase research aims to explore how well this treatment works and its potential for targeted radioisotope therapy, especially since previous studies showed that a similar dual-target tracer could better detect certain tumor metastases compared to single-target tracers. In this trial, all participants will first undergo a whole-body 68Ga-TATE-RGD PET/CT scan within one week. They will then receive a single intravenous injection of 177Lu-TATE-RGD at doses ranging from 1.48 to 3.33 GBq (40-100 mCi) within one week after the scan. Blood samples will be collected at several time points up to 168 hours after injection to measure radioactivity. Multiple imaging sessions will be conducted from 3 to 168 hours post-injection to analyze radiation dose and evaluate treatment response. Participants will be monitored through blood tests and imaging to assess how the drug is processed in the body and how tumors respond. The main measurement is the standardized uptake value of 177Lu-TATE-RGD in normal organs and tumors, tracked over an average of six months. Adverse events will also be collected for two months to monitor safety. This study is expected to continue until early 2025, providing valuable information on the therapy's effects and tolerability.

Researchers are evaluating the safety and effectiveness of a new molecular probe called 18F-FAPI-YQ104, which targets fibroblast activation protein (FAP), for early tumor diagnosis. This observational study focuses on patients with lung cancer, pancreatic cancer, neuroendocrine tumors, and thyroid cancer. The goal is to verify how well this probe works in detecting tumors during clinical use. Participants will receive an intravenous injection of the 18F-FAPI-YQ104 probe followed by a PET-CT examination to capture detailed images of tumor lesions. The study will observe the probe's uptake in tumor sites, measured by SUVmax values 60 minutes after administration. No additional treatment is given; instead, the study monitors the imaging results to assess the probe's diagnostic potential. During the study, participants will undergo PET-CT scans and other imaging tests such as CT or MRI. Researchers will evaluate the images to measure tumor activity and probe uptake. Safety assessments include checking kidney and liver function, blood counts, and monitoring for allergic reactions. The study will last from April 2025 to March 2026 and includes adults aged 18 to 75 years who have confirmed tumors and meet health criteria.

Researchers are evaluating the optimization of 18F-DOPA PET/CT imaging in specific patient groups including pediatric patients with congenital hyperinsulinism or neuroblastoma, pediatric and adult patients with neuroendocrine tumors or brain tumors, and adults suspected of Parkinson's disease or Lewy body dementia. The study aims to improve image quality using a new digital PET/CT scanner and intravenous furosemide, while also exploring gallbladder activity patterns related to dopaminergic degeneration. Participants will receive an intravenous injection of 18F-DOPA, with some also receiving a single intravenous dose of furosemide. The study includes a primary objective of assessing image quality improvements in the pelvis area and a secondary objective examining gallbladder activity patterns using dynamic imaging in a subgroup. Imaging data will be compared to previous scans with older technology. During the study, participants will undergo PET/CT scans, with measurements of lesion size and activity, bladder activity, and image artifact scoring. A questionnaire will screen for gallbladder disease history. The research team will analyze the imaging results and gallbladder activity patterns, with follow-up assessments occurring within one to three months. The total planned enrollment is 800 patients over approximately five years, with detailed monitoring of image optimization and gallbladder activity.

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 safety and sensitivity of a new imaging agent called 61Cu-NODAGA-LM3 compared to the standard 68Ga-DOTATOC for PET/CT scans in patients with well-differentiated bronchopulmonary and gastroenteropancreatic neuroendocrine tumors (NET). These tumors arise from neuroendocrine cells, often grow slowly, and may be metastatic at diagnosis. The study aims to improve diagnostic accuracy using this novel radiolabeled somatostatin receptor antagonist, which may offer advantages such as longer half-life and better tumor imaging contrast. Participants will receive a single intravenous dose of 61Cu-NODAGA-LM3 followed by up to three PET/CT scans. They will be randomly assigned to have the 61Cu-NODAGA-LM3 PET/CT either before or after their routine 68Ga-DOTATOC PET/CT, which is part of standard care. This open-label, randomized, controlled study takes place at one center and compares these two imaging approaches within a 24-hour to 4-week window. During the study, safety is monitored by tracking adverse events up to 18 hours after injection. Researchers will assess the sensitivity of 61Cu-NODAGA-LM3 imaging one hour after injection and evaluate various measures including tumor uptake, biodistribution, and patient preferences. Blood samples will be collected at multiple time points to study drug concentration and clearance. The total study duration spans from baseline assessments through imaging and follow-up, helping to understand the potential of 61Cu-NODAGA-LM3 in managing neuroendocrine tumors.

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.