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:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
NCT ID:
NCT01673906
Eligibility Criteria:
Inclusion Criteria:
1. Patients affected by proved MEN-I, in whom a neoplasm in the duodenal-pancreatic area is suspected.
2. Patients with clinical diagnosis of carcinoid syndrome.
3. Patients with clinical diagnosis of Zollinger-Ellison syndrome.
4. Patients with insulinoma, as proved by fasting test.
5. Patient with clinical pictures and laboratory findings suggesting other functional or non-functional NET.
6. Patients who had previously undergone surgery, including total and subtotal pancreatectomy, or a duodenotomy, intended as curative for a histologically confirmed NET.
7. Patients who were diagnosed with NET metastasis with unknown primary location of the disease.
8. Patients undergoing diagnostic work-up for a periduodenal or pancreatic lesion incidentally found during abdominal ultrasound (not performed for suspicion of a NET) and with ultrasonographic characteristics (rounded, hypoechoic or egg-eye, well demarcated) suspicious for NET.
9. Patients undergoing diagnostic work-up for a periduodenal or pancreatic lesion incidentally found during TC (not performed for suspicion of a NET) and with radiological characteristics (well demarcated, hypervascular) suspicious for NET.
Exclusion criteria:
1. Patient unwilling, or unable to consent.
2. Pregnancy, or lactation.
3. Age \<18 years
4. Known diagnosis of duodenal-pancreatic NET.
5. Patients with concomitant life-threatening disease.
6. Patients who had already undergone PET or EUS, in the last six months. In particular patients should be excluded from the study, when a lesion in the duodenal-pancreatic area, with characteristic suspicious for a NET, is incidentally diagnosed by PET, or EUS, or when a previously unsuspected diagnosis of NET is suggested by EUS-FNA of a pancreatic lesion.
7. Patients who had previously undergone total gastrectomy or pancreatectomy will be included in the study, but they will not undergo EUS.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01673906
Study Brief:
Protocol Section:
NCT01673906