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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Netherlands
UMC Utrecht
RECRUITING
Utrecht
Contact Information
Primary
Joanne M de Laat, Md, PhD
J.M.deLaat-4@umcutrecht.nl
+31302507397
Backup
Gerlof D Valk, MD, PhD
G.D.Valk@umcutrecht.nl
+31302507397
Time Frame
Start Date: 2022-05-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 20
Treatments
Experimental: High-dose-high precision MR-guided radiotherapy
Radiotherapy for pancreatic NET will be delivered in an image-guided, hypofractionated scheme of 5 fractions of 8 Gy, prescribed to 95% of the planning target volume (PTV). Treatment is delivered on alternate days 2 or 3 times a week with a maximum overall treatment time of 14 days on the 1.5T MR-Linac (Elekta Unity MR-Linac).~The Gross Tumor Volume (GTV) is defines as the pNET visible on pre-treatment CT and MRI scan. No clinical target volume (CTV) is used. The PTV is made by adding a 3mm margin to the GTV.~The treatment plan is a 9-14 field intensity modulated radiotherapy (IMRT) plan with dose prescribed to 95% of the PTV. While respecting the dose constraints to adjacent tissues
Sponsors
Collaborators: University Medical Center Groningen, Radboud University Medical Center, Maastricht University Medical Center, Erasmus Medical Center, Leiden University Medical Center
Leads: J.M. de Laat

This content was sourced from clinicaltrials.gov