FLT PET: A Pilot Study in Lymphoma Patients
Condition: Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Hodgkin Disease
Study type: Observational

Summary: 
      Background: Residual masses on follow-up surveillance imaging are frequently detected in
      paediatric patients with Hodgkin's lymphoma and non-Hodgkin's lymphoma. The residual mass may
      consist of inflammatory, fibrous or necrotic tissue, or it could represent residual tumor. In
      most cases, positron emission tomography (PET) with 2-[fluorine-18]-fluoro-2-deoxy-D-glucose
      (FDG) is useful for distinguishing tumor from fibrosis. However, FDG is not tumor-specific,
      and increased accumulation of the tracer may be seen in a variety of benign entities which
      can give rise to false-positive or equivocal FDG PET findings. Alternatively, the uptake of
      3'-deoxy-3'-[fluorine-18]-fluorothymidine (FLT) reflects cellular proliferation, and may
      prove to be a reliable method in resolving equivocal FDG PET findings. Indeed, several
      studies have demonstrated that FLT can be safely administered to children, and in some cases
      be more useful than FDG PET in differentiating between infection or inflammation and
      malignancy. This study hypothesizes that FLT PET can be used as an adjunct imaging modality
      in paediatric lymphoma patients with equivocal interim or post-therapy FDG PET findings, and
      that this technique can provide additional diagnostic information which will be useful in
      distinguishing fibrotic or necrotic residual mass lesions from those that may be harbouring
      malignancy.
    

Detailed description: 
      This is a prospective pilot study evaluating the clinical use of FLT PET in paediatric
      patients with Hodgkin's lymphoma (HL) or non-Hodgkin's lymphoma (NHL). The overall objective
      of this trial is to assess the feasibility of using FLT PET as an adjunct imaging modality to
      follow-up paediatric lymphoma patients whose interim or post-therapy FDG PET scan is
      interpreted as being equivocal. The primary outcome measure is to obtain a preliminary
      estimate of the diagnostic performance (including the sensitivity, specificity and accuracy)
      of adjunct FLT PET. This pilot study will yield sufficient preliminary data to help justify
      and design a subsequent larger study of FLT PET in paediatric lymphoma patients.

      This study is open only to HL and NHL patients whose interim or post-therapy FDG PET scan is
      interpreted as being equivocal and in whom it is not possible resolve the exam results using
      other conventional imaging techniques such as CT or MRI. All FLT PET image findings will be
      presented to the treating physician(s) responsible for managing the care of any patient
      enrolled in this trial. Treating physicians will continue to use routine practices to resolve
      equivocal FDG PET findings.
    

Intervention name(s): FDG PET; FLT PET
Intervention type(s): Procedure; Procedure
Intervention description(s): Each patient will receive a single intravenous injection of FDG (5.18 MBq/kg (0.14 mCi/kg)) using a minimum dose of 37 MBq (1 mCi) up to a maximum of 370 MBq (10 mCi) with an accepted 10%-20% variation since dose variation can occur when small concentrated volumes of FDG are being drawn up or radioactive decay has reduced the amount of available.; The FLT PET scan will be performed 1-5 days after FDG PET in order to ensure consistency between imaging findings. Each patient will receive a single intravenous injection of FLT (5.18 MBq/kg (0.14 mCi/kg)) using a minimum dose of 37 MBq (1 mCi) up to a maximum of 370 MBq (10 mCi) with an accepted 10%-20% variation since dose variation can occur when small concentrated volumes of FLT are being drawn up or radioactive decay has reduced the amount of available.
Other intervention name(s): 2-[fluorine-18]-fluoro-2-deoxy-D-glucose (FDG); 3'-deoxy-3'-[fluorine-18]-fluorothymidine (FLT)
Intervention MeSH terms: Deoxyglucose; Fluorides
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric lymphoma
      
Keywords: Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma; Possitron Emission Therapy (PET); FDG PET; FLT PET; Pediatrics