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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-012225-12-IT

Enrollment

Registered

2009-10-01

Start date

2009-09-15

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

head and neck cancer. MEDRA code has not been found. MedDRA version: 9.1 Level: LLT Classification code 10026184 MedDRA version: 9.1 Level: LLT Classification code 10026161 MedDRA version: 9.1 Level: LLT Classification code 10025963 MedDRA version: 9.1 Level: LLT Classification code 10025923

Interventions

Product Name: 64Cu-ATSM Product Code: 64Cu-ATSM Pharmaceutical Form: Solution for injection INN or Proposed INN: 64Cu-ATSM Concentration unit: MBq megabecquerel(s) Concentration type: equal Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Italy

Outcome results

None listed

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