PHASE III CLINICAL TRIAL TO ASSESS THE ADDED ROLE OF 68Ga-DOTANOC PET-CT IN PATIENTS WITH NEUROENDOCRINE TUMORS - ND
- Conditions
- neuroendocrine tumorsMedDRA version: 9.1Level: PTClassification code 10052399
- Registration Number
- EUCTR2010-023827-34-IT
- Lead Sponsor
- POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
->18 years patients with known neuroendocrine tumors for staging, therapy response evaluation or restaging;
- availability to participate in the study expressed by a written informed consent;
- patients able to be submitted to PET-CT.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- patients not able to partecipate in this protocol study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1)the development of 68Ga-DOTANOC process production in Radiopharmacy ?????<br>2)the evaluation of the role of 68Ga-DOTANOC PET-CT in patients with neuroendocrine tumors as:<br>•Gastroenteropancreatic tumors (GEP) both functioning and not functioning (according to the specific hormonal evaluation);<br>•Medullary thyroid carcinoma;<br>•Functioning and not functioning paraganglioma;<br>•Neuroblastoma of adult;<br>•Pituitary adenoma;<br>•Merkel cell carcinoma;<br>•Lung and thymus neuroendocrine tumors;<br>•Prostate carcinoma with neuroendocrine differentiation;<br>•Neurondocrine metastasis from unknown primary tumor.;Secondary Objective: Any modifications in patient diagnostic or therapeutic management will also be recorded.;Primary end point(s): nd
- Secondary Outcome Measures
Name Time Method