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Completed

NCT Number: NCT02601547

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Toulouse

Toulouse, 31000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET-FDG brain imaging and NPT

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.

Other names: 18F-Fluoro-Desoxy-Glucose brain imaging and NPT

Primary outcomes

  1. Change of Standard Uptake Value

    Time frame: 1 month after chemotherapy termination

  2. Change of Standard Uptake Value

    Time frame: 12 months after one year of achievement of chemotherapy

Secondary outcomes

  1. change of functional learning test (WAIS)

    Time frame: 1 month after chemotherapy termination

  2. change of functional learning test (WAIS)

    Time frame: 12 months after one year of achievement of chemotherapy

  3. change of depression scale

    Time frame: 1 month after chemotherapy termination

  4. change of depression scale

    Time frame: 12 months after one year of achievement of chemotherapy

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: LYMCOTEP

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Nov 10, 2015
Registry last updated
Nov 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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