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PHASE III CLINICAL TRIAL TO ASSESS THE ADDED ROLE OF 68Ga-DOTANOC PET-CT IN PATIENTS WITH NEUROENDOCRINE TUMORS - ND

PHASE III CLINICAL TRIAL TO ASSESS THE ADDED ROLE OF 68Ga-DOTANOC PET-CT IN PATIENTS WITH NEUROENDOCRINE TUMORS - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-023827-34-IT
Enrollment
Unknown
Registered
2010-12-24
Start date
2011-05-02
Completion date
Unknown
Last updated
2016-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neuroendocrine tumors MedDRA version: 9.1 Level: PT Classification code 10052399

Interventions

Product Name: 68GA-Dotanoc Pharmaceutical Form: Solution for infusion CAS Number: 1040397-47-4 Concentration unit: MBq megabecquerel(s) Concentration type: equal Concentration number: 200-

Sponsors

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: - patients not able to partecipate in this protocol study.

Design outcomes

Primary

MeasureTime frame
Main Objective: 1) the development of 68Ga-DOTANOC process production in Radiopharmacy ????? 2) the evaluation of the role of 68Ga-DOTANOC PET-CT in patients with neuroendocrine tumors as: • Gastroenteropancreatic tumors (GEP) both functioning and not functioning (according to the specific hormonal evaluation); • Medullary thyroid carcinoma; • Functioning and not functioning paraganglioma; • Neuroblastoma of adult; • Pituitary adenoma; • Merkel cell carcinoma; • Lung and thymus neuroendocrine tumors; • Prostate carcinoma with neuroendocrine differentiation; • 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—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026