Know Cancer

or
forgot password

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


N/A
10 Years
18 Years
Open (Enrolling)
Both
Osteonecrosis, Acute Lymphoblastic Leukaemia, Lymphoblastic Lymphoma

Thank you

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

Name

Location