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Precision Radiotherapy Using MR-linac for Pancreatic Neuroendocrine Tumours in MEN1 Patients

ConditionsNeuroendocrine Tumor of PancreasMultiple Endocrine Neoplasia Type 1
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJ.M. de Laat

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • High-dose-high precision MR-guided radiotherapy

    Radiation

    MR-guided radiotherapy as described in the group information

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: High-dose-high precision MR-guided radiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in tumor size

Change in maximal diameter of pNET measured at follow-up MRI

Time frame
12 months

Secondary outcomes

1

Tumour progression

Number of patients with signs of growth or metastasis at follow-up

Time frame
12 months
2

Pancreatic surgery

Number of patients that require surgical treatment following MRgRT

Time frame
12 months
3

Toxicity of radiotherapy

Toxicity of radiotherapy graded according to Common Terminology Criteria for Adverse Events v4.0 scale

Time frame
12 months
4

Health-related quality of life by SF-36

Short Form Health Survey 36 items

Time frame
6 months, 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Source ClinicalTrials.gov
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