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

This is a diagnostic prospective multicenter study. This study will be conducted in 32 centers of the Société Française des Cancers et Leucémies de l'Enfants et de l'Adolescent (SCFE) in patients with non-Hodgkin lymphoma and treated according to recommendations of the SFCE for each type of non-Hodgkin lymphoma. All patients will have a PET / CT associated with conventional imaging time of remission assessment. Histological examination of residual tumor will be conducted whenever practicable in patients with pathologic residual image on conventional imaging and / or PET / CT. A central review of conventional imaging examinations and PET / CT will be performed independently from each other.

Moreover, whenever possible, patients will have a PET / CT at diagnosis and an early PET / CT (between J8 and J28 according to the type of lymphoma and toxicities due to treatment). The results of the early PET / CT should not lead to treatment modifications.

In case of residual tumor at remission assessment, therapeutics changes as recommended therapeutic protocols will be based on histologic findings and not on the results of PET / CT alone.

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Key information

Conditions

Non-Hodgkin Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

2 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val De Marne, 94805, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)
Age > 2 years and < 21 years
Treated in a SFCE protocol
Treated in a center with the possibility of organizing a PET / CT at the time of remission assessment
Affiliation to a social security system
Possible follow-up for at least 2 years
written informed consent signed by the parents or parental authority or the patient himself if he is over 18 years

Exclusion criteria

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

Treatment and study plan

PET / CT

Device

Primary outcomes

PET sensitivity according to Juweid et Cheson criterias

Time frame: 28 days after inclusion

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Collaborators

Société Française des Cancers et Leucémies de l'Enfant et de l'Adolescent (SFCE)

Registry information

Official study 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

Acronym: TEP-LYMPHOME

Important dates

Study start: 2011
Primary completion: 2015
Study completion: 2018
First posted: Jul 2, 2015
Registry last updated: Jun 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed