PET-based Evaluation of Chemotherapy-induced Brain Damage in Lymphoma (LYMCOTEP)
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|ClinicalTrials.gov Identifier: NCT02601547|
Recruitment Status : Completed
First Posted : November 10, 2015
Last Update Posted : November 10, 2015
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Device: PET-FDG brain imaging and NPT||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PET-based Evaluation of Chemotherapy-induced Brain Damage in Lymphoma Patients -Implication in the Evaluation of Neuro-cognitive Function Alteration (LYMCOTEP)|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
Device: PET-FDG brain imaging and NPT
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.
Other Name: 18F-Fluoro-Desoxy-Glucose brain imaging and NPT
- Change of Standard Uptake Value [ Time Frame: 1 month after chemotherapy termination ]
- Change of Standard Uptake Value [ Time Frame: 12 months after one year of achievement of chemotherapy ]
- change of functional learning test (WAIS) [ Time Frame: 1 month after chemotherapy termination ]
- change of functional learning test (WAIS) [ Time Frame: 12 months after one year of achievement of chemotherapy ]
- change of depression scale [ Time Frame: 1 month after chemotherapy termination ]
- change of depression scale [ Time Frame: 12 months after one year of achievement of chemotherapy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02601547
|CHU de Toulouse|
|Toulouse, France, 31000|
|Principal Investigator:||Anne Julian, MD PhD||University Hospital, Toulouse|