FMISO F18 PET/CT as marker of hypoxia in patients undergoing radio- and chemotherapy
- Conditions
- Patients complying with tumours and undergoing radio- and/or chemotherapy for whom is mandatory to know the hypoxia componentMedDRA version: 14.1Level: SOCClassification code 10022891Term: InvestigationsSystem Organ Class: 10022891 - InvestigationsMedDRA version: 14.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-002819-26-IT
- Lead Sponsor
- CENTRO DI RIFERIMENTO ONCOLOGICO DI BASILICATA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
Age <18 yrs. o >90 yrs
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): metastatic assessment and correlation to neoplastic markers;Timepoint(s) of evaluation of this end point: 48 months