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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
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

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.

Condition or disease Intervention/treatment Phase
Lymphoma Device: PET-FDG brain imaging and NPT Not Applicable

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.


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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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France
CHU de Toulouse
Toulouse, France, 31000
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Anne Julian, MD PhD University Hospital, Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02601547     History of Changes
Other Study ID Numbers: 09 154 02
First Posted: November 10, 2015    Key Record Dates
Last Update Posted: November 10, 2015
Last Verified: November 2015

Keywords provided by University Hospital, Toulouse:
Positron-Emission Tomography
chemotherapy-induced brain damage
neuro-cognitive function alteration

Additional relevant MeSH terms:
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Lymphoma
Brain Injuries
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries