Main
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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:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02488369 |
Date of registration:
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29/06/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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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:
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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:
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March 31, 2011 |
Target sample size:
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230 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02488369 |
Study type:
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Interventional |
Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Non-Hodgkin Lymphoma
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Intervention(s)
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Device: PET / CT
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Primary Outcome(s)
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PET sensitivity according to Juweid et Cheson criterias
[Time Frame: 28 days after inclusion]
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Secondary ID(s)
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2010/1651
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2010-A01154-35
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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