Evaluation of a new surgical technique in neuroendocrine tumors
- Conditions
- Gastro-entero-pancreatic neuroendocrine tumorsMedDRA version: 20.0Level: PTClassification code 10057270Term: Neuroendocrine carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-005202-10-IT
- Lead Sponsor
- ISTITUTO EUROPEO DI ONCOLOGIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 5
a) Patients of both sexes aged over 18 years
b) Patients with histologically documented diagnosis of GEP-NET candidates for surgery R0 or R2.
c) Presence of a PET / CT with 68Ga-DOTATOC showing a significant uptake (> than the liver) of the tracer at the tumor (SSR-positive)
d) Functionality marrow, liver, kidney and heart check with instrumental tests (ECG) and laboratory (blood count, creatinine, transaminases, gamma-GT, alkaline phosphatase, sodium and potassium)
e) Signed informed consent
f) a negative pregnancy test (blood dosage of beta HCG) not older than 7 days is required in women in premenopausal status
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 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1
a) Patient history of malignant tumors with treatment ongoing except for basal cell carcinoma in situ and cervical cancer radically removed
b) Known intolerance to medical contrast medium and / or previous anaphylactic shock
c) Women who are pregnant or nursing, GEP-NET recurrence and considered inoperable
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method