MedPath

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 activty
Therapeutic area: Diseases [C] - Cancer [C04]
MedDRA version: 14.1Level: SOCClassification code 10022891Term: InvestigationsSystem Organ Class: 10022891 - Investigations
MedDRA 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
NameTimeMethod
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
NameTimeMethod
Secondary end point(s): metastatic assessment and correlation to neoplastic markers;Timepoint(s) of evaluation of this end point: 48 months
© Copyright 2025. All Rights Reserved by MedPath