Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2025-12-24 @ 12:12 PM
NCT ID:
NCT05037461
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05037461
Study Brief:
Protocol Section:
NCT05037461