Using MR-guided radiotherapy to treat pancreatic tumors in MEN1 patients
PRIME Study: Precision Radiotherapy Using MR-linac for Pancreatic Neuroendocrine Tumours in MEN1 Patients
This study is testing if a new type of targeted radiation therapy can safely treat small pancreatic tumors in patients with Multiple Endocrine Neoplasia type 1 (MEN1) without the need for surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Utrecht) |
| Trial ID | NCT05037461 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of high-dose, high-precision MR-guided radiotherapy (MRgRT) as a less invasive treatment option for pancreatic neuroendocrine tumors (pNET) in patients with Multiple Endocrine Neoplasia type 1 (MEN1). Given the high morbidity associated with surgical interventions for pNET, the study aims to provide an alternative approach for managing small tumors, particularly those between 1.0 and 3.0 cm. Patients will be assessed based on specific tumor growth criteria and monitored for treatment outcomes. The goal is to improve quality of life while reducing the need for surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are MEN1 patients with pancreatic neuroendocrine tumors measuring between 1.0 and 3.0 cm, particularly those showing moderate growth.
Not a fit: Patients with larger tumors over 3 cm, rapidly growing lesions, or symptomatic pNET due to hormone production may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for invasive surgeries and improve the quality of life for MEN1 patients with pNET.
How similar studies have performed: While MR-guided radiotherapy is a novel approach for this specific patient population, similar techniques have shown promise in treating other types of tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
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. 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
Where this trial is running
Utrecht
- UMC Utrecht — Utrecht, Netherlands (Recruiting)
Study contacts
- Study coordinator: Joanne M de Laat, Md, PhD
- Email: J.M.deLaat-4@umcutrecht.nl
- Phone: +31302507397
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.