About this trial
Patients with the Multiple Endocrine Neoplasia type 1 (MEN1) syndrome are genetically predisposed for developping multiple pancreatic neuro-endocrine tumours (pNET). The management of small (pNET) in both MEN1 and sporadic cases, pose a major clinical challenge. At present, pancreatic surgery is the only curative treatment but it is associated with high morbidity. To reduce the morbidity ascosiated with surgery and thereby potentially improve quality of life for MEN1 patients introduction of less invasive techniques for treatment of pNET is important. High-dose-high precision MR-guided radiotherapy (MRgRT) holds promise as a new less invasive treatment option for pNET. The aim of this study is to assess efficiacy and safety of MRgRT for treatment of pNET in MEN1 patients.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- High-dose-high precision MR-guided radiotherapy
Treatment groups
Sponsors and collaborators
J.M. de Laat
Lead sponsor
UMC Utrecht
Sponsor institution
Radboud University Medical Center
Collaborator
Erasmus Medical Center
Collaborator
Maastricht University Medical Center
Collaborator
Leiden University Medical Center
Collaborator
University Medical Center Groningen
Collaborator