PET-based Evaluation of Chemotherapy-induced Brain Damage in Lymphoma Patients -Implication in the Evaluation of Neuro-cognitive Function Alteration (LYMCOTEP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change of Standard Uptake Value
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
intervention
- 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.
干预措施: PET-FDG brain imaging and NPT (Device)
结局指标
主要结局
Change of Standard Uptake Value
时间窗: 12 months after one year of achievement of chemotherapy
Change of Standard Uptake Value
时间窗: 1 month after chemotherapy termination
次要结局
- change of functional learning test (WAIS)(12 months after one year of achievement of chemotherapy)
- change of depression scale(12 months after one year of achievement of chemotherapy)
- change of functional learning test (WAIS)(1 month after chemotherapy termination)
- change of depression scale(1 month after chemotherapy termination)