Accuracy and clinical impact of 68-Ga-labeled octreotide analogues PET in diagnosis and staging of duodeno-pancreatic neuroendocrine tumours; proposal of a multicenter, prospective clinical trial

AZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA0 个研究点目标入组 142 人开始时间: 2012年3月29日最近更新: 2014年1月27日

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•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

•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.

发起方

AZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA