Role of 64Cu-ATSM PET/CT for the localization of hypoxic areas in uterine cervical cancer - 64Cu-ATSM-UTERO-01/2009

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-011682-91-IT

Enrollment

Registered

2009-10-01

Start date

2009-09-29

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

Patients affected by uterine cervical cancer (sensitivity for localizing area of hypoxia within tumoral masses will be evaluated ) MedDRA version: 9.1 Level: LLT Classification code 10007493

Interventions

Product Name: 64Cu-ATSM Pharmaceutical Form: Solution for injection Current Sponsor code: 64Cu-ATSM Concentration unit: MBq megabecquerel(s) Concentration type: equal Concentration number: 400- Produ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. adult women (age >18years) 2. patients diagnosed with uterine cervical cancer (stage II and III) and scheduled for radiation therapy as the only treatment. 3. no previous chemiotherapy treatment before enrollment 4. 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. patients diagnosed with uterine cervical cancer and scheduled for radiation therapy as the only treatment. 2. adult women (age >18years) 3. signed informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: The main 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 serviva and overall servival). 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 main 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 serviva and overall servival). 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