Patients suspected to be affected by neuroendocrine duodeno-pancreatic neoplasm. MedDRA version: 14.1 Level: HLGT Classification code 10014713 Term: Endocrine neoplasms malignant and unspecified System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: 68Ga-octreotide analog
Product Code: NA
Pharmaceutical Form: Kit for radiopharmaceutical preparation
Current Sponsor code: 68Ga-octreotide analog
Concentration unit: MBq megabecquerel(s)
Sponsors
AZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to compare accuracy of MDCT and PET in the diagnosis of primary duodeno-pancreatic NET.;Secondary Objective: to compare accuracy of MDCT, EUS and PET in the diagnosis of primary duodeno-pancreatic NET. To evaluate clinical impact of PET. To compare accuracy of MDCT and PET in the staging of duodeno-pancreatic NET.;Primary end point(s): to compare accuracy of MDCT and PET in the diagnosis of primary duodeno-pancreatic NET, calculated on a patient basis.;Timepoint(s) of evaluation of this end point: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Impact of PET.2.Operative characteristics of MDCT, EUS and PET, in the diagnosis of primary duodeno-pancreatic NET, calculated on a patient basis and on lesion basis. 3.Median diameter and ranges of lesions diagnosed by each techniques. 4.Changes in EUS findings, after disclosure of PET results.5.Operative characteristics of MDCT and PET in the diagnosis of secondary NET, calculated on a patient basis and on a lesion basis 6.Incidence of secondary lesions, according to the T of the primary tumour.7.Diagnosis of new lesions during the follow up.8.Incidence of adverse events of the technique under investigation 9. Accuracy of EUS-FNA, according to the histological diagnosis (when available) and/or to the clinical follow;Timepoint(s) of evaluation of this end point: 3 years | — |
Countries
Italy
Contacts
Public ContactU.O. di Medicina Nucleare
AZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA
Outcome results
None listed