Ongoing Clinical Trials for Phaeochromocytoma
There are currently 3 ongoing clinical trials investigating new imaging techniques and targeted treatments for phaeochromocytoma and related tumors. These studies are taking place in the Netherlands, Italy, Poland, France, and Spain, and focus on improving tumor detection through advanced PET-CT scanning and evaluating radioactive treatments that target specific receptors on tumor cells.
Clinical trial locations
- France
- Italy
- Netherlands
- Poland
- Spain
Study on [18F]mFBG PET-CT Imaging for Patients with Pheochromocytoma
This clinical trial is investigating a new imaging method to better detect tumors in patients with phaeochromocytoma, which are rare tumors that typically develop in the adrenal glands. The study uses an advanced scanning technique called PET-CT combined with a special tracer substance.
Main inclusion criteria: Participants must be at least 18 years old and provide written consent to join the study. They need to have either a confirmed diagnosis or strong test results suggesting phaeochromocytoma, such as elevated levels of certain hormones in the blood. Surgery must be planned as part of their treatment. A recent CT scan taken within the past 8 weeks is required, and participants should have an ECOG performance status of Grade 0 to 2, meaning they can perform most daily activities independently or with minimal assistance.
Main exclusion criteria: The trial does not specify detailed exclusion criteria in the provided information, but standard medical contraindications for imaging procedures and injection safety would apply.
Focus and goal: The primary goal is to compare how effectively the new [18F]mFBG PET-CT scan detects tumor lesions compared to conventional CT scans. Researchers will examine the optimal timing for performing the scan by comparing images taken at different time points after injection. The study will also correlate the imaging findings with actual tumor characteristics and monitor the safety of the imaging agent by tracking any side effects.
Investigational agent: The study uses [18F]mFBG, also known as M-(18F)-Fluorobenzylguanidine or Florbenguane (18F). This is a radioactive tracer given through an intravenous injection. It works by targeting specific features of phaeochromocytoma cells, making the tumors more visible on the PET-CT scan and potentially helping doctors identify tumors that might be missed by standard imaging.
Study on the Effectiveness of Lutetium (177Lu) Edotreotide for Patients with Neuroendocrine Tumors and Other SSTR-Positive Tumors
This trial examines a targeted radiation treatment for patients with neuroendocrine tumors and other tumors that have specific receptors on their surface, including phaeochromocytomas and paragangliomas. The treatment delivers radiation directly to cancer cells while minimizing damage to healthy tissue.
Main inclusion criteria: Participants must be at least 18 years old and able to provide informed consent. They need a confirmed diagnosis of a neuroendocrine tumor or another SSTR-positive tumor, either through biopsy or strong evidence from CT or MRI scans. The tumor must show significant uptake on imaging tests, indicating it has the receptors targeted by the treatment. Participants must have measurable or evaluable disease that has progressed within the last 12 months despite standard treatments. A life expectancy of more than 6 months is required, along with an ECOG performance status of 2 or less. Adequate blood, liver, and kidney function is essential. Female participants must not be pregnant or breastfeeding and must use effective birth control.
Main exclusion criteria: Patients without SSTR-positive tumors are excluded, as the treatment requires these specific receptors to work effectively. Those not affected by neuroendocrine tumors, phaeochromocytomas, or paragangliomas cannot participate. Patients outside the specified age range or belonging to vulnerable populations requiring special protection are also excluded.
Focus and goal: The study aims to evaluate how effective the treatment is at controlling disease progression. Researchers will track whether patients achieve complete response, partial response, or stable disease. The trial also monitors treatment safety by checking for side effects throughout and after the treatment period. Quality of life assessments using standardized questionnaires are conducted at various points to understand the broader impact of treatment on patients’ daily lives.
Investigational drug: 177Lu-DOTATOC is a radiopharmaceutical administered through intravenous infusion. It combines a radioactive substance with a targeting molecule that attaches to somatostatin receptors on tumor cells. Once bound, the radioactive component delivers focused radiation to destroy cancer cells while sparing surrounding healthy tissue.
Study on the Safety of Lutetium (177Lu) Oxodotreotide, L-Lysine Hydrochloride, and L-Arginine Hydrochloride in Adolescents with Neuroendocrine Tumors and PPGLs
This trial specifically focuses on adolescent patients with gastroenteropancreatic neuroendocrine tumors, phaeochromocytomas, and paragangliomas. It evaluates both the safety and how the body absorbs radiation from a targeted treatment approach.
Main inclusion criteria: Participants must be between 12 and 17 years old at enrollment. They need to have a confirmed diagnosis of GEP-NET or PPGL that has spread or cannot be surgically removed, verified by histological testing. The tumors must express somatostatin receptors, confirmed by imaging performed within 3 months before joining, showing that the tumor absorbs the tracer substance at least as much as normal liver tissue. Participants must have a Karnofsky score or Lansky Play-Performance Scale score of 50 or higher, indicating reasonable ability to perform daily activities. Both the parent or guardian and the adolescent must provide consent to participate.
Main exclusion criteria: Patients without somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors cannot join. Those without phaeochromocytoma or paragangliomas are excluded, as are patients outside the specified age range. Other exclusions include being pregnant or breastfeeding, inability to follow study procedures or attend required visits, recent participation in another clinical trial, certain medical conditions that might interfere with treatment, medications that could affect study results, and allergies to the study medication or its components.
Focus and goal: The primary purpose is to assess the safety of Lutathera in adolescent patients and understand how their bodies absorb the radiation from this treatment. The study involves monitoring participants over an extended period, up to 36 months during active treatment, followed by long-term follow-up extending up to five years. Researchers pay particular attention to radiation doses absorbed by organs such as the kidneys and bone marrow, tracking both immediate and long-term adverse effects.
Investigational drugs: Lutathera, containing lutetium (177Lu) oxodotreotide, is the main treatment. It is a radiopharmaceutical that delivers targeted radiation to tumor cells expressing somatostatin receptors. LysaKare, containing L-lysine hydrochloride and L-arginine hydrochloride, is administered alongside Lutathera to protect the kidneys during treatment. These amino acids help reduce radiation exposure to kidney tissue.
Summary
The three ongoing trials for phaeochromocytoma represent different approaches to improving care for patients with this rare tumor. One trial focuses purely on advancing diagnostic imaging capabilities in the Netherlands, while two trials in Southern and Central Europe investigate targeted radioactive treatments.
Geographically, the trials are distributed across five European countries, with one study conducting research across multiple nations. The Netherlands hosts the imaging-focused trial, Italy leads the adult-focused treatment study, and Poland, France, and Spain collaborate on the adolescent safety study.
A common theme across the treatment trials is the focus on somatostatin receptor targeting. Both treatment studies use radioactive substances that bind to these specific receptors found on tumor cells, representing a personalized medicine approach. The diagnostic trial similarly aims to improve tumor detection through targeted imaging agents.
Notably, one trial specifically addresses the adolescent population aged 12-17 years, recognizing that young patients may have different safety profiles and needs compared to adults. This study extends monitoring up to five years after treatment, acknowledging the importance of long-term safety data in younger patients.
The trials collectively address different stages of patient care: better diagnosis through improved imaging, effective treatment for adults with progressive disease, and careful safety evaluation in younger patients. Together, they contribute to a more comprehensive understanding of how to detect and treat phaeochromocytoma and related tumors.
