Comparison among 68-Ga-labeled octreotide analogues PET, TC and endoscopic ultrasonography in the study of duodeno-pancreatic neuroendocrine tumors.

Active, not recruiting

Conditions: Patients suspected to be affected by neuroendocrine duodeno-pancreatic neoplasm.
MedDRA version: 14.1Level: HLGTClassification code 10014713Term: Endocrine neoplasms malignant and unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2012-000994-22-IT

Lead Sponsor: AZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 142

Inclusion Criteria

1. Patients affected by proved MEN-I, in whom a neoplasm in the duodenopancreatic area is suspected. 2. Patients with clinical diagnosis of carcinoid syndrome or Zollinger-Ellison syndrome. 3. Patients with insulinoma, as proved by fasting test. 4. Patient with clinical pictures and laboratory findings suggesting other infrequent islet cell tumours. 5. Patients with subtle clinical abnormalities, or laboratory findings (for instance elevated serum chromogranine A levels) suggesting a NET. 6. Patients who had previously undergone surgery intended as curative for a histologically confirmed NET. 7. 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. 8. Patients who were diagnosed with NET metastasis with unknown primary location of the disease.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

1. Patient unwilling, or unable to consent. 2. Pregnancy, or lactation. 3. Age < 18 years 4. Known diagnosis of duodeno-pancreatic NET. 5. Patients with concomitant life-threatening disease. 6. Patients who had already undergone any of the tests under investigation (MDCT, PET, EUS) in the last six months. In particular patients should be excluded from the study, when a lesion in the duodeno-pancreatic area, with characteristic suspicious for a NET, is incidentally diagnosed by any of the techniques object of the study, namely MDCT, PET, or EUS. 7. Patients who had previously undergone total gastrectomy or pancreasectomy will be included in the study, but they will not undergo EUS.