Non-Hodgkin LymphomaTEP-LYMPHOMENCT02488369
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
A study testing PET / CT in people with Non-Hodgkin Lymphoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 2 to 21 years
- Conditions the study is for
- Non-Hodgkin Lymphoma
- What is being tested?
- PET / CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2011to 25 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val De Marne, 94805
About this study
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
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.
- Conditions
- Non-Hodgkin Lymphoma
- Being tested
- PET / CT
- Keywords
- Children and adolescents
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET / CTDevice
| Study group | Role | What they receive |
|---|---|---|
| Patients with non-Hodgkin's lymphoma | Experimental | Not described Receives: Device: PET / CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET sensitivity according to Juweid et Cheson criterias
Measured: 28 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study start31 Mar 2011
- Primary completion3 Aug 2015
- Study completion25 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Société Française des Cancers et Leucémies de l'Enfant et de l'Adolescent (SFCE)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02488369
- Sponsor's protocol ID
- 2010-A01154-35
- Other IDs
- 2010/1651
- Acronym
- TEP-LYMPHOME
- Status last verified
- Jun 2019
- First submitted
- 29 Jun 2015
- Last updated
- 18 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02488369
- Acronym / sponsor ID
- TEP-LYMPHOME / 2010-A01154-35
- Conditions
- Non-Hodgkin Lymphoma
- Keywords
- Children and adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Collaborators
- Société Française des Cancers et Leucémies de l'Enfant et de l'Adolescent (SFCE)
- Study start
- 31 Mar 2011 (actual)
- Primary completion
- 3 Aug 2015 (actual)
- Study completion
- 25 Jan 2018 (actual)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with non-Hodgkin's lymphoma | Experimental | Device: PET / CT |
Who may qualify
- Ages
- 2 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- All cases of NHL corresponding to one of the following histologies:
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET / CT | Device | Patients with non-Hodgkin's lymphoma |
Primary outcome
PET sensitivity according to Juweid et Cheson criterias
Time frame: 28 days after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET / CT in people with Non-Hodgkin Lymphoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET sensitivity according to Juweid et Cheson criterias (time frame: 28 days after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2019.