NCT04005703

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2011

Longer than P75 for all trials

Geographic Reach
4 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2013

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

July 2, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

5.5 years

First QC Date

July 2, 2013

Last Update Submit

November 2, 2020

Conditions

Hodgkin's Lymphoma

Keywords

Malignant lymphomaHodgkin's diseaseImagingWhole-Body MRIPET/CTRadiation

Outcome Measures

Primary Outcomes (4)

  • Staging (Ann Arbor)

    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.

    Day 1

  • Early treatment response assessment (Cheson criteria)

    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.

    2 months

  • Restaging at end of therapy (Cheson criteria)

    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.

    6 months

  • Follow up for 3 years after end of treatment

    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.

    3 years

Secondary Outcomes (2)

  • Image quality

    Day 1, 2 months, 6 months

  • Interobserver variability of WB-MRI for staging, early response assessment and restaging at end of therapy

    Day 1, 2 months, 6 months

Study Arms (1)

Pediatric Hodgkin's lymphoma

Children with newly diagnosed Hodgkin's lymphoma

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

LKH-Universitätsklinikum Graz

Graz, Austria

Location

Ospedale Giannina Gaslini

Genova, Italy

Location

Academic Medical Center Amsterdam

Amsterdam, Netherlands

Location

VU University Medical Center

Amsterdam, Netherlands

Location

University Medical Center St. Radboud

Nijmegen, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

University Medical Center Utrecht

Utrecht, Netherlands

Location

HUMI Vall d'Hebron

Barcelona, Spain

Location

MeSH Terms

Conditions

Hodgkin DiseaseLymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Rutger AJ Nievelstein, MD PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 2, 2013

First Posted

July 2, 2019

Study Start

June 1, 2011

Primary Completion

December 1, 2016

Study Completion

September 1, 2020

Last Updated

November 3, 2020

Record last verified: 2020-11

Locations

IT(1)AU(1)NL(5)ES(1)