NCT05037461Active, not recruiting
Precision Radiotherapy Using MR-linac for Pancreatic Neuroendocrine Tumours in MEN1 Patients
PRIME Study: Precision Radiotherapy Using MR-linac for Pancreatic Neuroendocrine Tumours in MEN1 Patients
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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 (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 25 Aug 2021
- Start date
- 27 Jun 2022
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- J.M. de Laat
- Diseases
- Neuroendocrine tumours, Pancreatic cancer
- NCT number
- NCT05037461
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 27 Jun 2022 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- concurrent treatment with a somatostatin analog
- concurrent treatment with chemotherapy
- peptide receptor radionuclide therapy in the past 12 months
- MRI contraindications as per usual clinical care, such as claustrophobia and metal or electronic implants not compatible with MRI.
Other illness
- Suspected malignant pNET as per the tumour board assessment, including the criteria:
- history of radiotherapy in the upper abdominal region
- (Other) metastatic disease
Other
- 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
- Pregnancy
- WHO performance score 3-4
Criteria the registry did not label
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UMC Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.