Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05037461

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

Led by J.M. de Laat · Updated on 2024-12-18

20

Participants Needed

1

Research Sites

239 weeks

Total Duration

On this page

Sponsors

J

J.M. de Laat

Lead Sponsor

R

Radboud University Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with pNET lesions measuring between 2 cm and 3 cm
  • Patients with pNET lesions between 1.0 and 2.0 cm showing moderate growth (2-4 mm/year) on follow-up scans
  • Patients with pNET lesions between 1.0 and 2.0 cm showing minimal growth (1 mm/year) confirmed on 3 or more sequential scans
  • Patients with remaining 1.0 to 2.0 cm lesions after previous removal of a larger lesion
  • Patients with an indication for surgery
Not Eligible

You will not qualify if you...

  • pNET lesions larger than 3 cm
  • Rapidly growing pNET lesions with growth over 4 mm per year
  • Symptomatic pNET due to hormone production, except gastrinomas in the duodenum submucosa
  • Receiving somatostatin analog treatment
  • Receiving chemotherapy
  • Received peptide receptor radionuclide therapy in the past 12 months
  • History of radiotherapy in the upper abdomen
  • Contraindications for MRI such as claustrophobia or incompatible implants
  • Pregnancy
  • Presence of metastatic disease
  • WHO performance status 3 or 4

AI-Screening

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Trial Site Locations

Total: 1 location

1

UMC Utrecht

Utrecht, Netherlands, 3584 CX

Actively Recruiting

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Research Team

J

Joanne M de Laat, Md, PhD

CONTACT

G

Gerlof D Valk, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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