Whole-body MRI in Pediatric Hodgkin's Lymphoma
Condition: Hodgkin's Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Observational

Summary: 
      Background:

      The assessment of extent of disease (staging) and response to therapy (restaging) is
      performed with computed tomography (CT) scan, 18F-fluorodeoxyglucose positron emission
      tomography (FDG-PET scan) or integrated FDG-PET/CT. Whole-body MRI with diffusion weighted
      imaging (WB-MRI with DWIBS) is a radiation-free method which allows imaging of the body with
      excellent soft tissue contrast in a single examination and could be an attractive alternative
      to FDG-PET and CT for the staging and restaging of malignant lymphomas in children.

      Aim of the study:

      The aims of this study are to compare the diagnostic performance of whole-body MRI (including
      DWIBS) to FDG-PET/CT and/or CT for the initial staging, early response assessment and
      restaging after completion of therapy in children with Hodgkin's lymphoma.

      Study design:

      Patients eligible for enrollment in this multicenter, prospective, diagnostic cohort study
      are children aged 8-18 years, with histologically confirmed Hodgkin's lymphoma, who are
      treated according to the EuroNet-PHL-C1 protocol (or trial with similar imaging strategy) in
      one of the participating centers. Patients will undergo WB-MRI in addition to the protocolar
      imaging routinely done (FDG-PET(/CT) and CT scan) at 3 time-points: at initial staging, after
      2 chemotherapy cycles and at end of treatment. The investigators expect to enrol 75 patients
      in a 3 year study period. Staging and restaging results of WB-MRI (according to the Ann Arbor
      and Cheson classification, respectively) will be compared to those of FDG-PET(/CT) and CT.
      Clinical and radiological follow-up after 6 months will be used to solve any disagreements
      between FDG-PET, CT and WB-MRI. Additionally, the investigators will collect 3 year follow-up
      clinical data and data on follow-up imaging from the hospital charts of the patients, to
      better assess the prognostic value of FDG-PET and WB-MRI.
    

Detailed description: 
      Background:

      The malignant lymphomas, Hodgkin´s lymphoma (HL) and non-Hodgkin´s lymphoma (NHL), comprise
      approximately 10% of childhood cancers. The assessment of extent of disease (staging) and
      response to therapy (restaging) is performed with computed tomography (CT) scan,
      18F-fluorodeoxyglucose positron emission tomography (FDG-PET scan) or integrated FDG-PET/CT.
      Staging and restaging are important for choice of treatment and for determining prognosis.
      Unfortunately, FDG-PET and CT are accompanied by a significant amount of radiation exposure
      which may induce second cancers. New magnetic resonance imaging (MRI) techniques offer an
      alternative way for staging and follow-up of cancers. Whole-body MRI with diffusion weighted
      imaging (WB-MRI with DWIBS) is a radiation-free method which allows imaging of the body with
      excellent soft tissue contrast in a single examination and could be an attractive alternative
      to FDG-PET and CT for the staging and restaging of malignant lymphomas in children.

      Aim of the study:

      The aims of this study are to compare the diagnostic performance of whole-body MRI (including
      DWIBS) to FDG-PET/CT and/or CT for the initial staging, early response assessment and
      restaging after completion of therapy in children with Hodgkin's lymphoma.

      Study design:

      Patients eligible for enrollment in this multicenter, prospective, diagnostic cohort study
      are children aged 8-18 years, with histologically confirmed Hodgkin's lymphoma, who are
      treated according to the SKION / EuroNet-PHL-C1 protocol (or trial with similar imaging
      strategy) in one of the participating centers. Patients will undergo WB-MRI in addition to
      the protocolar imaging routinely done (FDG-PET(/CT) and CT scan) at 3 time-points: at initial
      staging, after 2 chemotherapy cycles and at end of treatment. We expect to enrol 75 patients
      in a 3 year study period. Staging and restaging results of WB-MRI (according to the Ann Arbor
      and Cheson classification, respectively) will be compared to those of FDG-PET(/CT) and CT.
      All imaging modalities will be assessed by a radiologist and nuclear medicine physician in a
      blinded fashion, using standardized score forms. Findings of FDG-PET and CT together will
      serve as the reference standard. Clinical and radiological follow-up after 6 months will be
      used to solve any disagreements between FDG-PET, CT and WB-MRI. Additionally, at least 3 year
      follow-up clinical data and data on follow-up imaging will be collected from the hospital
      charts of the patients, to better assess the prognostic value of FDG-PET and WB-MRI.

      Clinical/scientific relevance:

      This study aims to assess the accuracy of WB-MRI compared to FDG-PET(/CT) and CT in staging
      and response assessment of Hodgkin lymphoma. The results of this study can contribute to the
      development of evidence based 'radiation reduced' imaging protocols in Hodgkin's lymphoma.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients, aged 8-18 years, with newly diagnosed Hodgkin's lymphoma, who will undergo PET/CT
        for staging, early response assessment and restaging at completion of therapy (imaging
        standards according to the Euronet-PHL-C1 protocol).
      
Keywords: Malignant lymphoma; Hodgkin's disease; Imaging; Whole-Body MRI; PET/CT; Radiation