NCT05037461: PRIME

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

Recruiting now NA Last updated 18 December 2024

What this trial tests

NA trial testing High-dose-high precision MR-guided radiotherapy in Neuroendocrine Tumor of Pancreas in 20 participants. Currently enrolling.

Timeline

1 May 2022

Primary endpoint
1 December 2025

1 December 2026

Quick facts

Lead sponsor	J.M. de Laat
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 May 2022
Primary completion	1 December 2025
Estimated completion	1 December 2026
Sites	1 location across Netherlands

Drugs / interventions tested

• High-dose-high precision MR-guided radiotherapy

Conditions studied

• Neuroendocrine Tumor of Pancreas — all drugs for Neuroendocrine Tumor of Pancreas →
• Multiple Endocrine Neoplasia Type 1 — all drugs for Multiple Endocrine Neoplasia Type 1 →

Sponsor

J.M. de Laat

Who can join

18 and older, any sex, with Neuroendocrine Tumor of Pancreas or Multiple Endocrine Neoplasia Type 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Stereotactic Magnetic Resonance-Guided Adaptive and Non-Adaptive Radiotherapy on Combination MR-Linear Accelerators: Current Practice and Future Directions.
   Bryant JM, Weygand J, Keit E, Cruz-Chamorro R, et al · · 2023 · cited 24× · PMID 37046741 · DOI 10.3390/cancers15072081
2. Precision radiotherapy using MR-linac for pancreatic neuroendocrine tumors in MEN1 patients (PRIME): a protocol for a phase I-II trial, and systematic review on available evidence for radiotherapy of pNETs.
   van Vliembergen ENM, Eijkelenkamp H, Valk GD, Vriens MR, et al · · 2023 · cited 4× · PMID 37305036 · DOI 10.3389/fendo.2023.994370