Precision Radiotherapy using MR-linac for Pancreatic Neuroendocrine Tumours in MEN1 patients

Phase 2

Conditions: Neuroendocrine tumor of the pancreas
endocrine neoplasm of the pancreas
10052547
10017990
10014713

Registration Number: NL-OMON52098

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

MEN1 patients diagnosed with pNET meeting the following criteria:
- 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.

Exclusion Criteria

- Suspected malignant pNET as per the tumour board assessment, including the
criteria:
- 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
- concurrent treatment with chemotherapy
- peptide receptor radionuclide therapy in the past 12 months
- history of radiotherapy in the upper abdominal region
- MRI contraindications as per usual clinical care, such as claustrophobia and
metal or electronic implants not compatible with MRI.
- Pregnancy
- (Other) metastatic disease
- WHO performance score 3-4

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is the change in tumour size at control MRI at 12 months<br /><br>follow-up.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Key secondary outcomes include indication for pancreatic resection, safety<br /><br>(toxicity), radiological tumour characteristics, quality of life, and endocrine<br /><br>and exocrine pancreas function, metastases free survival, overall survival and<br /><br>tumour characteristics on follow-up MRI.</p><br>