Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02601547
Acronym
LYMCOTEP
Enrollment
18
Registered
2015-11-10
Start date
2010-09-30
Completion date
2013-03-31
Last updated
2015-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

Positron-Emission Tomography, chemotherapy-induced brain damage, neuro-cognitive function alteration

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.

Interventions

DEVICEPET-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.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change of Standard Uptake Value1 month after chemotherapy termination

Secondary

MeasureTime frame
change of functional learning test (WAIS)1 month after chemotherapy termination
change of depression scale1 month after chemotherapy termination

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026