Precision Radiotherapy Using MR-linac for Pancreatic Neuroendocrine Tumours in MEN1 Patients

Launched by J.M. DE LAAT · Aug 31, 2021

Keywords

ClinConnect Summary

This clinical trial, called the PRIME study, is exploring a new treatment option for patients with multiple endocrine neoplasia type 1 (MEN1) who have pancreatic neuroendocrine tumors (pNET). These tumors can be tricky to manage, especially when they are small, and while surgery is the typical way to treat them, it can lead to significant complications. This study is testing a type of radiotherapy called MR-guided radiotherapy (MRgRT), which is a less invasive approach that may reduce the need for surgery and improve patients' quality of life.

To participate in this trial, patients should have pNET tumors that are between 1 and 3 centimeters in size, with specific growth rates defined by the study. The trial is open to all patients aged 65 to 74, regardless of gender. Those who meet the eligibility criteria will be closely monitored during the study to assess how effective and safe this new treatment is. It's important to note that patients with larger or rapidly growing tumors, or those with certain other health conditions, may not qualify for this trial. If you think you might be a candidate, discussing this option with your healthcare provider could be a good next step.

Gender

ALL

Eligibility criteria

• All patients meeting the following criteria will be assessed for in the tumour board:
• • lesions measuring between 2cm and 3cm.
• • pNET lesions with a size between 1.0 and 2.0 cm and moderate growth of the lesion (2-4 mm/ year) on sequential follow-up scans.
• • pNET lesions with a size between 1.0 and 2.0 cm and minimal growth of the lesion (1 mm/ year) reconfirmed on 3 or more sequential follow-up scans.
• • Patients with in situ remaining 1.0 - 2.0 cm lesions after previous resection of a larger lesion.
• • All patients with such lesion and an indication for surgery are considered eligible for participation in the PRIME study.
• Exclusion Criteria:
• * Suspected malignant pNET as per the tumour board assessment, including the criteria:
• • pNET lesions of more than 3 cm in size
• • rapid growth of pNET lesions with more than 4mm per year
• • Symptomatic pNET because of hormone production, with the exception of gastrinomas which are located in the submucosa of the duodenum
• • concurrent treatment with a somatostatin analog
• • concurrent treatment with chemotherapy
• • peptide receptor radionuclide therapy in the past 12 months
• • history of radiotherapy in the upper abdominal region
• • MRI contraindications as per usual clinical care, such as claustrophobia and metal or electronic implants not compatible with MRI.
• • Pregnancy
• • (Other) metastatic disease
• • WHO performance score 3-4