Role of 18F-FLT PET/CT for evaluating suspect lesions in patients with malignant lymphoma - 18F-FLT-LINFOMA-03/2009

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-012561-56-IT

Enrollment

100

Registered

2009-10-02

Start date

2009-09-29

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malignant lymphoma (evaluating suspect lesions) MedDRA version: 12.0 Level: LLT Classification code 10025315 Term: Lymphoma malignant

Interventions

Product Name: 18-Fluor-desoxy-fluortimidine Product Code: 18F-FLT Pharmaceutical Form: Solution for injection INN or Proposed INN: 18-Fluor-desoxy-fluortimidine Current Sponsor code: 18F-FLT Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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) . 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	—

Measure

Time frame

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) . 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

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Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026