PET-based Evaluation of Chemotherapy-induced Brain Damage in Lymphoma

Study Overview
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Brief Summary
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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.

Detailed Description
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Alteration of neuro-cognitive function induced by chemotherapy has been extensively documented in breast carcinoma patients. These modifications consist in the decrease of memory, intellectual capacity, speed analysis, and represent a real limitation for patients, sometimes durable. Aggressive lymphomas (diffuse large B cell lymphomas/DLBCL) represent a common disease, the standard being Rituximab-Cyclophosphamide-Doxorubicine-Vincristine-Prednisone (RCHOP) regiment which contains, as for breast cancer patients, anthracyclines. However, very little is known about the incidence and severity of cognitive function alteration in these patients. The occurrence of such complications should also be facilitated because of frail cognitive states due to age and co-morbidity. Cognitive function alteration is usually measured by neuropsychological tests (NPT) which are easy to handle and sensitive, but could lack specificity, in the context of general degradation which is often observed in hematological patients. Positron emission tomography 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. In our center, the investigators have already described glucidic hypometabolism in several brain territories associated with Alzheimer's disease and other dementia. Moreover, uptake quantification and topography are useful markers for determining the type of the disease and progression. PET-FDG received very little attention for the detection of chemotherapy-induced brain damages.

Official Title
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PET-based Evaluation of Chemotherapy-induced Brain Damage in Lymphoma Patients -Implication in the Evaluation of Neuro-cognitive Function Alteration (LYMCOTEP)

Conditions
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Lymphoma

Intervention / Treatment
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* Device: PET-FDG brain imaging and NPT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention<br>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. NPT scores (3 values) should be correlated with the five better values on PET-FDG. Each patient will be monitored along a time period of 18 months. 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. | Device: PET-FDG brain imaging and NPT<br>* PET-FDG brain imaging and NPT should be performed at T0, at Tf (within 1 month after chemotherapy termination), T+12. Several PET parameters should be calculated: minimal SUV (Standard Uptake Value), maximum SUV, and mean SUV for each of 20 cortical and sub-cortical territories.<br>* Other names: 18F-Fluoro-Desoxy-Glucose brain imaging and NPT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Standard Uptake Value |  | 1 month after chemotherapy termination | 
| Change of Standard Uptake Value |  | 12 months after one year of achievement of chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of functional learning test (WAIS) |  | 1 month after chemotherapy termination | 
| change of functional learning test (WAIS) |  | 12 months after one year of achievement of chemotherapy | 
| change of depression scale |  | 1 month after chemotherapy termination | 
| change of depression scale |  | 12 months after one year of achievement of chemotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Positron-Emission Tomography, chemotherapy-induced brain damage, neuro-cognitive function alteration