Trial Information
Part I: Incidence, Clinical Course and Significance of MRI for Early Diagnosis of Osteonecrosis in Children and Adolescents With Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL) Part II: Susceptibility for Aseptic Osteonecroses in Children and Adolescents With Chemotherapy for ALL or LBL
Inclusion Criteria:
- diagnosis of ALL or LBL
- age at diagnosis of ALL or LBL ≥ 10 and < 18 years
- study patient of AIEOP( Associazione Italiana Ematologia ed Oncologia
Pediatrica)-BFM, COALL or NHL-BFM in Germany
- treatment in a hospital participating in OPAL
- written informed consent
Exclusion Criteria:
- relapse of ALL or LBL
- every non evidence based treatment (pharmacological, orthopaedic-conservative,
orthopaedic operative) aiming at the prevention of ON during study participation
- pacemaker, other MRI prohibited devices
- metal implants in the field of view, other MRI prohibited implants
- pregnancy
- claustrophobia
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
occurence of early ON stages
Outcome Description:
Calculation of the rate of by MRI detectable (still) asymptomatic patients with early ON stages (I and II) within the patients who develop symptomatic ON in the further course
Outcome Time Frame:
6 years
Safety Issue:
No
Principal Investigator
Michaela Kuhlen, Dr. med.
Investigator Role:
Study Chair
Investigator Affiliation:
Heinrich-Heine University, Duesseldorf
Authority:
Germany: Ethics Commission
Study ID:
DKS 2011.11
NCT ID:
NCT01619124
Start Date:
March 2012
Completion Date:
March 2018
Related Keywords:
- Osteonecrosis
- Acute Lymphoblastic Leukaemia
- Lymphoblastic Lymphoma
- osteonecrosis
- children
- pediatric
- acute lymphoblastic leukaemia
- lymphoblastic lymphoma
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Lymphoma
- Osteonecrosis
- Lymphoma, Non-Hodgkin