NCT02488369

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2011

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2015

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2018

Completed
Last Updated

June 18, 2019

Status Verified

June 1, 2019

Enrollment Period

4.3 years

First QC Date

June 29, 2015

Last Update Submit

June 14, 2019

Conditions

Non-Hodgkin Lymphoma

Keywords

Children and adolescents

Outcome Measures

Primary Outcomes (1)

  • PET sensitivity according to Juweid et Cheson criterias

    28 days after inclusion

Study Arms (1)

Patients with non-Hodgkin's lymphoma

EXPERIMENTAL
Device: PET / CT

Interventions

PET / CTDEVICE
Patients with non-Hodgkin's lymphoma

Eligibility Criteria

Age2 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gustave Roussy Cancer Campus Grand Paris

Villejuif, Val De Marne, 94805, France

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2015

First Posted

July 2, 2015

Study Start

March 31, 2011

Primary Completion

August 3, 2015

Study Completion

January 25, 2018

Last Updated

June 18, 2019

Record last verified: 2019-06

Locations

FR(1)