Ongoing Clinical Trials for Paraganglioma
Currently, there are 3 ongoing clinical trials investigating treatments and diagnostic methods for paraganglioma. These studies are being conducted across several European countries, including Italy, the Netherlands, Poland, France, and Spain. The trials focus on both targeted radioactive therapies and advanced imaging techniques to improve detection and treatment of these rare nerve tissue tumors.
Clinical trial locations
- France
- Italy
- Netherlands
- Poland
- Spain
Study on the Effectiveness of Lutetium (177Lu) Edotreotide for Patients with Neuroendocrine Tumors and Other SSTR-Positive Tumors
This trial is being conducted in Italy and focuses on evaluating the effectiveness of a targeted radiation treatment called 177Lu-DOTATOC. The treatment is designed for patients with neuroendocrine tumors and other tumors that are positive for a specific receptor known as SSTR, including paragangliomas and pheochromocytomas.
Who can participate: The trial is open to adults aged 18 and older who have a confirmed diagnosis of a neuroendocrine tumor or another SSTR-positive tumor. Participants must have a measurable or evaluable disease that shows significant uptake on imaging tests and has progressed within the last 12 months despite standard treatments. Female participants must not be pregnant or breastfeeding and must use effective birth control. Participants must have a life expectancy of more than 6 months and adequate blood, liver, and kidney function.
Who cannot participate: Patients without SSTR-positive tumors, those not affected by neuroendocrine tumors, paragangliomas, or pheochromocytomas, and individuals outside the specified age range are excluded. Vulnerable populations requiring special protection or care are also not eligible.
What the trial involves: The main goal of the study is to assess disease control rates, which include complete response, partial response, or stable disease. The treatment involves administering 177Lu-DOTATOC through an intravenous infusion in cycles. Throughout the treatment period, regular monitoring is conducted to evaluate the response to therapy and check for side effects. Follow-up assessments continue after treatment completion to monitor long-term outcomes and quality of life using standardized questionnaires and medical imaging such as MRI or CT scans.
Investigational treatment: The trial uses 177Lu-DOTATOC, a radiopharmaceutical that attaches to specific receptors on tumor cells. Once attached, the radioactive component helps destroy cancer cells while minimizing damage to surrounding healthy tissue.
Study on Using Exenatide PET/CT Imaging for Detecting Paragangliomas in Patients
This trial, taking place in the Netherlands, is testing a new imaging technique called Exendin PET/CT to determine if it can effectively detect paragangliomas. This imaging method uses a special substance called 68Ga-exendin-4 to help highlight tumors during scanning.
Who can participate: The trial is open to male and female patients with a confirmed diagnosis of a single paraganglioma identified through regular imaging tests, with no signs of the cancer having spread to other parts of the body. Participants must have undergone both CT and SSTR PET/CT scans, be scheduled for surgery, and be able to understand and sign informed consent. Vulnerable populations are excluded.
Who cannot participate: Patients not diagnosed with paragangliomas, those outside the specified age range, and individuals who are part of vulnerable populations requiring special protection are excluded.
What the trial involves: The study aims to determine the detection rate of paragangliomas using the Exendin PET/CT scan. Participants receive an intravenous injection or infusion of exenatide, followed by the 68Ga-exendin-4 PET/CT scan. The imaging results help guide surgical planning and are compared with other standard imaging techniques. Secondary objectives include identifying the optimal timing for imaging and exploring how the results relate to the genetic and histological characteristics of the tumors.
Investigational agent: The trial uses 68Ga-exendin-4, a special imaging agent that helps visualize paragangliomas on PET/CT scans. This is not a treatment but rather a diagnostic tool to help locate and assess these tumors.
Study on the Safety of Lutetium (177Lu) Oxodotreotide, L-Lysine Hydrochloride, and L-Arginine Hydrochloride in Adolescents with Neuroendocrine Tumors and PPGLs
This trial is being conducted across Poland, France, and Spain, focusing on adolescent patients with gastroenteropancreatic neuroendocrine tumors, pheochromocytoma, and paragangliomas. The study evaluates the safety of a treatment called Lutathera and how the body absorbs radiation from this therapy.
Who can participate: The trial is open to adolescents between 12 and 17 years old who have gastroenteropancreatic neuroendocrine tumors or paragangliomas that have spread or cannot be removed by surgery. These tumors must be confirmed by histological testing and must express somatostatin receptors, verified by imaging within 3 months of joining the study. Participants must have a Karnofsky score or Lansky Play-Performance Scale score of 50 or higher, indicating reasonable physical ability. Parents or guardians must provide informed consent, and the adolescent must also agree to participate.
Who cannot participate: Patients without somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors, pheochromocytoma, or paragangliomas are excluded. Those outside the specified age range, pregnant or breastfeeding individuals, patients who cannot follow study procedures, those who have participated in another recent clinical trial, individuals with medical conditions that might interfere with treatment, those taking medications that could affect results, and patients with allergies to the study medication are also excluded.
What the trial involves: The primary focus is evaluating the safety of Lutathera and assessing the radiation doses absorbed by organs such as the kidneys and bone marrow. Participants receive Lutathera intravenously along with LysaKare, which contains amino acids to protect the kidneys during treatment. The study includes monitoring for immediate adverse effects, short-term follow-up for six months after the last dose, and long-term follow-up extending up to five years to ensure continued safety and effectiveness.
Investigational treatment: The trial uses Lutathera, a radiopharmaceutical that delivers targeted radiation to cancer cells, helping to reduce tumor size and slow disease progression. It is administered alongside LysaKare for kidney protection.
Summary
The three ongoing clinical trials for paraganglioma demonstrate diverse approaches to improving both diagnosis and treatment of these rare tumors. Two trials focus on targeted radioactive therapies using lutetium-based compounds, with one specifically designed for adult patients and another dedicated to adolescent safety assessment. The third trial explores innovative imaging techniques that could enhance early detection capabilities.
Geographically, the trials are distributed across five European countries, with a multi-country study spanning Poland, France, and Spain, while Italy and the Netherlands host single-country trials. A notable observation is the focus on somatostatin receptor-positive tumors across multiple studies, highlighting the importance of this characteristic in both treatment targeting and patient selection. The inclusion of a pediatric-focused trial also addresses an important gap in treatment options for younger patients with these rare tumors.
