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

Lymphoma Clinical Trial

— LYMCOTEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02601547
• Other study ID #: 09 154 02
• Status: Completed
• Phase: N/A
• First received: September 29, 2015
• Last updated: November 9, 2015
• Start date: September 2010
• Est. completion date: March 2013

Study information

• Verified date: November 2015
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Brain Injuries
• Lymphoma

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Standard Uptake Value		1 month after chemotherapy termination	No
Primary	Change of Standard Uptake Value		12 months after one year of achievement of chemotherapy	No
Secondary	change of functional learning test (WAIS)		1 month after chemotherapy termination	No
Secondary	change of functional learning test (WAIS)		12 months after one year of achievement of chemotherapy	No
Secondary	change of depression scale		1 month after chemotherapy termination	No
Secondary	change of depression scale		12 months after one year of achievement of chemotherapy	No