RecruitingNot ApplicableNCT05037461

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


Sponsor

J.M. de Laat

Enrollment

20 participants

Start Date

May 1, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether precision radiation therapy using an MR-linac machine — which combines MRI imaging with radiation delivery — can safely treat small tumors in the pancreas caused by a hereditary condition called MEN1 (Multiple Endocrine Neoplasia type 1), potentially avoiding the need for surgery. **You may be eligible if...** - You have MEN1 and have a pancreatic neuroendocrine tumor (pNET) between 1 cm and 3 cm - Your tumor is growing (1–4 mm/year) or was left behind after prior surgery - Your tumor board has determined surgery is an option for you but you choose to explore alternatives **You may NOT be eligible if...** - Your tumor is larger than 3 cm or is growing rapidly (more than 4 mm/year) - Your tumor is causing hormone-related symptoms (except for gastrinomas in the small intestine) - You are currently on somatostatin analog or chemotherapy - You have received radiation in the upper abdomen before - You have MRI contraindications (claustrophobia, metal implants) - You are pregnant or have other sites of cancer spread - You have very poor health status (WHO performance score 3–4) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHigh-dose-high precision MR-guided radiotherapy

MR-guided radiotherapy as described in the group information


Locations(1)

UMC Utrecht

Utrecht, Netherlands

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NCT05037461


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