Role of 64Cu-ATSM PET/CT for the localization of hypoxic areas in head and neck cancer - 64-Cu-ATSM-CC-02/2009

• Conditions: head and neck cancer. MEDRA code has not been found.; MedDRA version: 9.1Level: LLTClassification code 10026184; MedDRA version: 9.1Level: LLTClassification code 10026161; MedDRA version: 9.1Level: LLTClassification code 10025963; MedDRA version: 9.1Level: LLTClassification code 10025923

• Registration Number: EUCTR2009-012225-12-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. patients diagnosed with head and neck cancer (stage III and IV) scheduled for radiation therapy as elective treatment.
2. age >18years
3. signed 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

1. pregnancy 2. breastfeeding 3. healthy volunteers 4. age<18 5. patients in emergency situations 6. patients of un sound mind 7. patients who dont sign the informed consent

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is the evaluation of 64Cu-ATSM PET/CT sensitivity for localizing area of hypoxia within tumoral masses;Secondary Objective: Secondary aim is the evaluation of the added value of 64Cu-ATSM PET/CT in comparison to 18F-FDG PET/CT (standard tracer routinely used for cancer staging before a radical treatment).;Primary end point(s): 64Cu-ATSM PET/CT sensitivity for localizing area of hypoxia within tumoral masses will be evaluated by comparing the results obtained with 64Cu-ATSM (in terms of lesion number and extent and tracer uptake) to the data obtained during the clinical follow up (disease free survival and overall survival). The 64Cu-ATSM PET/CT added value will be evaluated by comparing the results to the 18F-FDG PET/CT in terms of tracer distribution within the tumoral mass.