Patients complying with tumours and undergoing radio- and/or chemotherapy for whom is mandatory to know the hypoxia component MedDRA version: 14.1 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations MedDRA version: 14.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: F18 FMISO
Product Code: NA
Pharmaceutical Form: Radiopharmaceutical precursor
Other descriptive name: F18 FMISO
Concentration unit: MBq megabecquerel(s)
Concentration type: equal
Concent
Sponsors
CENTRO DI RIFERIMENTO ONCOLOGICO DI BASILICATA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients for whom is mandatory to assess the hypoxia and to monitor therapy efficay early Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Age 90 yrs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: impact of PET/CT F18 FMISO in predicting relapse and in identifying patients who may take advantage from intensive care;Secondary Objective: analysis of HEAT-SHOCK protein TRAP1 expression involved in tumour cells protection;Primary end point(s): Diagnostic accuracy of F18 FMISO PET/CT;Timepoint(s) of evaluation of this end point: 48 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): metastatic assessment and correlation to neoplastic markers;Timepoint(s) of evaluation of this end point: 48 months | — |
Countries
Italy
Contacts
Public ContactMedicina Nucleare
IRCCS CROB centro di riferimento oncologico di basilicata
Outcome results
None listed