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

Non-Hodgkin Lymphoma Clinical Trial

— TEP-LYMPHOME  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02488369
• Other study ID #: 2010-A01154-35
• Secondary ID: 2010/1651
• Status: Completed
• Phase: N/A
• Start date: March 31, 2011
• Est. completion date: January 25, 2018

Study information

• Verified date: June 2019
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: January 25, 2018
• Est. primary completion date: August 3, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin Lymphoma

Intervention

Device:
• PET / CT

Locations

Country	Name	City	State
France	Gustave Roussy Cancer Campus Grand Paris	Villejuif	Val De Marne

Sponsors (2)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris	Société Française des Cancers et Leucémies de l'Enfant et de l'Adolescent (SFCE)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PET sensitivity according to Juweid et Cheson criterias		28 days after inclusion