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PRIME study: precision radiotherapy using MR-linac for pancreatic neuroendocrine tumours in MEN1 patients

NCT ID NCT05037461

NEW Sponsor: J.M. de Laat Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Adenoma, Islet Cell multiple endocrine neoplasia type 1 pancreatic neuroendocrine tumor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple endocrine neoplasia type 1 Neuroendocrine tumor of pancreas

Contacts and locations

Locations

  • UMC Utrecht

    Utrecht, Utrecht, 3584 CX, Netherlands

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