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

NCT ID: NCT02601547

Last Updated: 2015-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2013-03-31

Brief Summary

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

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

intervention

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.

Group Type: EXPERIMENTAL

PET-FDG brain imaging and NPT

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

18F-Fluoro-Desoxy-Glucose brain imaging and NPT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne Julian, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

CHU de Toulouse

Toulouse, , France

Countries

France

Other Identifiers

09 154 02

Identifier Type: -

Identifier Source: org_study_id