Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Whole-body MRI in Pediatric Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04005703
Recruitment Status : Active, not recruiting
First Posted : July 2, 2019
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
Stichting Kinderen Kankervrij (KiKa)
Information provided by (Responsible Party):
R.A.J. Nievelstein, UMC Utrecht

Brief 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.


Condition or disease
Hodgkin's Lymphoma

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.


Layout table for study information
Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Whole-body MRI for Initial Staging, Early Response Assessment and Restaging After Completion of Therapy in Pediatric Hodgkin's Lymphoma.
Actual Study Start Date : June 2011
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : May 2020


Group/Cohort
Pediatric Hodgkin's lymphoma
Children with newly diagnosed Hodgkin's lymphoma



Primary Outcome Measures :
  1. Staging (Ann Arbor) [ Time Frame: Day 1 ]
    The primary outcome parameter will be the clinical stage according to WB-MRI (including DWIBS) and according to FDG-PET/CT. This clinical stage will be determined according to the Ann Arbor classification system for initial staging.

  2. Early treatment response assessment (Cheson criteria) [ Time Frame: 2 months ]
    The primary outcome parameter will be the clinical stage according to WB-MRI (including DWIBS) and according to FDG-PET/CT. This clinical stage will be determined according to the Cheson criteria for early response assessment.

  3. Restaging at end of therapy (Cheson criteria) [ Time Frame: 6 months ]
    The primary outcome parameter will be the clinical stage according to WB-MRI (including DWIBS) and according to FDG-PET/CT. This clinical stage will be determined according to the Cheson criteria for restaging.

  4. Follow up for 3 years after end of treatment [ Time Frame: 3 years ]
    The percentage of relapse of Hodgkin lymphoma in this study cohort will be assessed by a 3-year follow-up of clinical and imaging data, and the percentage of true- versus false-positives on WB-MRI at end of treatment compared to PET/CT using this follow-up.


Secondary Outcome Measures :
  1. Image quality [ Time Frame: Day 1, 2 months, 6 months ]
    The secondary outcome will be a (subjective) assessment of image quality and presence of artefacts, for both T1-weighted and T2-weighted MR images, MR-DWI as well as PET/CT.

  2. Interobserver variability of WB-MRI for staging, early response assessment and restaging at end of therapy [ Time Frame: Day 1, 2 months, 6 months ]
    The interobserver variability of WB-MRI (including DWIBS) for staging, early response assessment and restaging at end of therapy will be determined for two observers.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

Inclusion Criteria:

  • male or female patients
  • age: 8-18 years
  • histologically proven Hodgkin's lymphoma
  • enrolled in the EuroNet-PHL-C1 trial (or trial with comparable imaging strategy)
  • patients scheduled for a FDG-PET/CT and/or CT of the body for initial staging, early response assessment (after two cycles of chemotherapy) or restaging
  • participant's parents (and participants >12 years of age) must willingly give written informed consent prior to each MRI
  • whole-body MRI/DWIBS has to be performed within 15 days before or after FDG-PET/CT or CT and the initial staging MRI should be performed before therapy has been started

Exclusion Criteria:

  • patients with a general contraindication for MRI (including cardiovascular pacemakers, claustrophobia)
  • patients who have had a previous malignancy
  • patients who are pregnant or nursing
  • patients in whom therapy has already started after FDG-PET/CT and/or CT and before the initial WB-MRI/DWIBS could be performed
  • apparent signs of resistance during MR examination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005703


Locations
Layout table for location information
Austria
LKH-Universitätsklinikum Graz
Graz, Austria
Italy
Ospedale Giannina Gaslini
Genova, Italy
Netherlands
Academic Medical Center Amsterdam
Amsterdam, Netherlands
VU University Medical Center
Amsterdam, Netherlands
University Medical Center St. Radboud
Nijmegen, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Spain
HUMI Vall d'Hebron
Barcelona, Spain
Sponsors and Collaborators
UMC Utrecht
Stichting Kinderen Kankervrij (KiKa)
Investigators
Layout table for investigator information
Principal Investigator: Rutger AJ Nievelstein, MD PhD UMC Utrecht

Layout table for additonal information
Responsible Party: R.A.J. Nievelstein, Principal Investigator, UMC Utrecht
ClinicalTrials.gov Identifier: NCT04005703     History of Changes
Other Study ID Numbers: KIKA project number 87
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019

Keywords provided by R.A.J. Nievelstein, UMC Utrecht:
Malignant lymphoma
Hodgkin's disease
Imaging
Whole-Body MRI
PET/CT
Radiation

Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases