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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)

Primary Purpose

Non-Hodgkin Lymphoma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PET / CT
Sponsored by
Gustave Roussy, Cancer Campus, Grand Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non-Hodgkin Lymphoma focused on measuring Children and adolescents

Eligibility Criteria

2 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gustave Roussy Cancer Campus Grand Paris

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with non-Hodgkin's lymphoma

Arm Description

Outcomes

Primary Outcome Measures

PET sensitivity according to Juweid et Cheson criterias

Secondary Outcome Measures

Full Information

First Posted
June 29, 2015
Last Updated
June 14, 2019
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Collaborators
Société Française des Cancers et Leucémies de l'Enfant et de l'Adolescent (SFCE)
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1. Study Identification

Unique Protocol Identification Number
NCT02488369
Brief 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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
March 31, 2011 (Actual)
Primary Completion Date
August 3, 2015 (Actual)
Study Completion Date
January 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Collaborators
Société Française des Cancers et Leucémies de l'Enfant et de l'Adolescent (SFCE)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma
Keywords
Children and adolescents

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with non-Hodgkin's lymphoma
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
PET / CT
Primary Outcome Measure Information:
Title
PET sensitivity according to Juweid et Cheson criterias
Time Frame
28 days after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Gustave Roussy Cancer Campus Grand Paris
City
Villejuif
State/Province
Val De Marne
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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