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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-013480-18-IT

Enrollment

Registered

2009-10-02

Start date

2009-03-05

Completion date

Unknown

Last updated

2021-10-26

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

Conditions

patients affected by neck and head cancer MedDRA version: 9.1 Level: SOC Classification code 10029104

Interventions

Product Name: 64CU-ATSM Pharmaceutical Form: Solution for injection Concentration unit: MBq megabecquerel(s) Concentration type: equal Concentration number: 370- Trade Name: FLUCIS Pharmaceutical For

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Italy

Outcome results

None listed

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