Precision Radiotherapy Using MR-linac for Pancreatic Neuroendocrine Tumours in MEN1 Patien
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 treat
| Condition(s) | Neuroendocrine Tumor of Pancreas, Multiple Endocrine Neoplasia Type 1 |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 l |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | J.M. de Laat |
| Locations | Utrecht, Netherlands |
| Start date | 2022-05-01 |
| NCT ID | NCT05037461 |
| Official listing | https://clinicaltrials.gov/study/NCT05037461 |