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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02488369
Date of registration: 29/06/2015
Prospective Registration: No
Primary sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Public title: Diagnostic Qualities of the Positron Emission Tomography Coupled to the Scanner (PET / CT) in the Assessment of Response to Non-Hodgkin's Lymphoma Therapy in Children and Adolescents TEP-LYMPHOME
Scientific title: Study on the Diagnostic Qualities of the Positron Emission Tomography Coupled to the Scanner (PET / CT) in the Assessment of Response to Non-Hodgkin's Lymphoma Therapy in Children and Adolescents
Date of first enrolment: March 31, 2011
Target sample size: 230
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02488369
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
France
Contacts
Key inclusion & exclusion criteria

Inclusion Criteria:

1. All cases of NHL corresponding to one of the following histologies:

- Burkitt and Burkitt-like (LB)

- Large cell B-cell lymphoma (LBGC)

- Primary mediastinal B cell lymphoma (LBPM)

- Lymphoblastic lymphoma (LL)

- Anaplastic large cell lymphoma (ALCL)

2. Age > 2 years and < 21 years

3. Treated in a SFCE protocol

4. Treated in a center with the possibility of organizing a PET / CT at the time of
remission assessment

5. Affiliation to a social security system

6. Possible follow-up for at least 2 years

7. written informed consent signed by the parents or parental authority or the patient
himself if he is over 18 years

Exclusion Criteria:

1. relapsing patients

2. Patients with absolute cons-indications to the achievement of a PET scan: pregnancy,
incontinence, poorly controlled diabetes or blood glucose> 10 mmol/l, alterations of
superior functions or claustrophobia, making the test impossible.

3. pre-existing or evolving infectious inflammatory disease making PET / CT difficult to
interpret



Age minimum: 2 Years
Age maximum: 21 Years
Gender: All
Health Condition(s) or Problem(s) studied
Non-Hodgkin Lymphoma
Intervention(s)
Device: PET / CT
Primary Outcome(s)
PET sensitivity according to Juweid et Cheson criterias [Time Frame: 28 days after inclusion]
Secondary Outcome(s)
Secondary ID(s)
2010/1651
2010-A01154-35
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Société Française des Cancers et Leucémies de l'Enfant et de l'Adolescent (SFCE)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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