Clinical trial · Interventional
PET-based Evaluation of Chemotherapy-induced Brain Damage in Lymphoma
PET-based Evaluation of Chemotherapy-induced Brain Damage in Lymphoma Patients -Implication in the Evaluation of Neuro-cognitive Function Alteration (LYMCOTEP)
NCT02601547CI-TRIAL-00019746LYMCOTEPcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Positron emission tomography (PET) with 18-fluoro-deoxy-glucose (PET-FDG) is emerging as a promising approach for detecting brain lesions in dementia, among which Alzheimer's disease has been the most widely studied.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET-FDG brain imaging and NPT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- intervention
- description
- 1. PET-FDG brain imaging and NPT should be performed at T0 (within the 15 days before chemotherapy), at Tf (within 1 month after chemotherapy termination), T+12 (Tf+12 months: within the first month after one year of achievement of chemotherapy). Several PET parameters should be calculated: minimal Standard Uptake Value (SUV), maximum SUV, and mean SUV for each of 20 cortical and sub-cortical territories. 2. NPT scores (3 values) should be correlated with the five better values on PET-FDG. 3. Each patient will be monitored along a time period of 18 months. 4. Duration of the study: one year to include the 15 patients with all the exams; 18 months follow-up for each; total of 30 months.
- interventionNames
- Device: PET-FDG brain imaging and NPT
Primary outcomes (2)
- measure
- Change of Standard Uptake Value
- timeFrame
- 1 month after chemotherapy termination
- measure
- Change of Standard Uptake Value
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * histologically documented DLBCL * previously untreated * with International Prognostic Index (IPI) 0 or 1, or 2 without general state alteration (OMS≤2) * submitted to RCHOP regimen (according to GELA's standard protocol) * normal pre-treatment brain CT scan * able to give informed consent * speaking well French language * benefiting from general medical insurance * registered in the national listing of patients for biomedical research. Exclusion Criteria: * IPI \> or =3 * medical history of another cancer, or psychiatric or pre-dementia disorder, or convulsion * barbituric regular use which can't be stop * human immunodeficiency virus (HIV) patients * unstable diabetes mellitus * pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.