Multiple Endocrine Neoplasia Type 1 Clinical Trial
— PRIMEOfficial title:
PRIME Study: Precision Radiotherapy Using MR-linac for Pancreatic Neuroendocrine Tumours in MEN1 Patients
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 1, 2026 |
Est. primary completion date | December 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | UMC Utrecht | Utrecht |
Lead Sponsor | Collaborator |
---|---|
J.M. de Laat | Erasmus Medical Center, Leiden University Medical Center, Maastricht University Medical Center, Radboud University Medical Center, University Medical Center Groningen |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in tumor size | Change in maximal diameter of pNET measured at follow-up MRI | 12 months | |
Secondary | Tumour progression | Number of patients with signs of growth or metastasis at follow-up | 12 months | |
Secondary | Pancreatic surgery | Number of patients that require surgical treatment following MRgRT | 12 months | |
Secondary | Toxicity of radiotherapy | Toxicity of radiotherapy graded according to Common Terminology Criteria for Adverse Events v4.0 scale | 12 months | |
Secondary | Health-related quality of life by SF-36 | Short Form Health Survey 36 items | 6 months, 12 months | |
Secondary | Health-related quality of life by Eq5D | EuroQol 5D instrument | 6 months, 12 months | |
Secondary | Health-related quality of life by PROMIS-29 | PROMIS 29 profile | 6 months, 12 months | |
Secondary | fasting glucose | fasting glucose in evaluation of endocrine and exocrine pancreatic function | 12 months | |
Secondary | blood cell count, | blood cell count in evaluation of endocrine and exocrine pancreatic function | 12 months | |
Secondary | serum iron | serum iron v | 12 month in evaluation of endocrine and exocrine pancreatic function | |
Secondary | vitamin B12 | vitamin B12 in evaluation of endocrine and exocrine pancreatic function | 12 months | |
Secondary | folate | folate in evaluation of endocrine and exocrine pancreatic function | 12 months | |
Secondary | faecal fat test | faecal fat test in evaluation of endocrine and exocrine pancreatic function | 12 months | |
Secondary | faecal trypsin | faecal trypsin in evaluation of endocrine and exocrine pancreatic function | 12 months | |
Secondary | faecal elastase | faecal elastase in evaluation of endocrine and exocrine pancreatic function | 12 months | |
Secondary | metastases free survival | Measured at follow-up imaging | 12 months | |
Secondary | overall survival | survival | 12 months |
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