Evaluation of tissue with low level of oxygene in patients affected by neck and brain cancer by PET/TC with Cu-ATSM (PET-ATSM-1). - ND

Phase 1

• Conditions: patients affected by neck and head cancer; MedDRA version: 9.1Level: SOCClassification code 10029104

• Registration Number: EUCTR2009-013480-18-IT
• Lead Sponsor: FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-02
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

-istologic diagnosis of neoplastic lesions of the larynx with total surgery indication -patology with tw dimensional measures -age > 18 yeras old -patient`s good compliance -written informed consent
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

-pregnancy women -glycaemia levels > 180mg/dl in the specific moment of the PET study with Fluorodesossiglucosio

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: adjustment of the study and feasibility of the PET study for the evaluation of of tissue with low level of oxygene in patients affected by neck and head cancer;Secondary Objective: correlatione between PET pictures and istopatological index;Primary end point(s): adjustment of the study and feasibility of the PET study for the evaluation of of tissue with low level of oxygene in patients affected by neck and head cancer