FLT F-18 PET/CT in diagnosis, staging and terapy assessmentin tumours with accelereted replicatio
- Conditions
- patients complying with cancer for whom is mandatory to know the replicative cellular activtyTherapeutic area: Diseases [C] - Cancer [C04]MedDRA 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)
- Registration Number
- EUCTR2012-002820-33-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
- 100
Inclusion Criteria
patients for whom is mandatory to know cellular replication and to monitor therpy efficacy 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 F18 FLT PET/CT for replicative evaluation in staging, restaging and therapy assessment of tumours rather than energetic metabolism;Secondary Objective: correlation to angiogenetic markers and EGFR mutations;Primary end point(s): Diagnostic accuracy of F18 FLT 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