Role of 18F-FLT PET/CT for evaluating suspect lesions in patients with malignant lymphoma - 18F-FLT-LINFOMA-03/2009
- Conditions
- malignant lymphoma (evaluating suspect lesions)MedDRA version: 12.0Level: LLTClassification code 10025315Term: Lymphoma malignant
- Registration Number
- EUCTR2009-012561-56-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
- 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
1.patients diagnosed with
2.Age > 18
3.signed 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
1.Pregnancy
2.Breastfeeding
3.Healthy volunteers
4.Age <18
5.Patients in emergency situation
6.patients of un sound mind
7.patients who dont sign the informed consent
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the specificity of 18F-FLT PET to identify the presence of residual disease or recurrence in patients affected by lymphoma. Patients will be selected on the basis of a 18F-FDG PET resulted positive or suspect for relapse or residual disease;Secondary Objective: To compare the specificity of 18F-FLT PET with that of 18F-FDG PET (the tracer usually employed at present)<br>. To evaluate the cost-effectiveness of 18F-FLT PET as compared to biopsy after 18F-FDG PET (the tracer usually employed at present);Primary end point(s): Specificity of 18F-FLT PET to identify areas of increased tracer uptake and thus increased proliferation will be evaluated by comparison of PET results with biopsy results
- Secondary Outcome Measures
Name Time Method