PET-based Evaluation of Chemotherapy-induced Brain Damage in Lymphoma (LYMCOTEP)

November 9, 2015 updated by: University Hospital, Toulouse

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31000
        • chu de Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 18F-Fluoro-Desoxy-Glucose brain imaging and NPT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of Standard Uptake Value
Time Frame: 1 month after chemotherapy termination
1 month after chemotherapy termination
Change of Standard Uptake Value
Time Frame: 12 months after one year of achievement of chemotherapy
12 months after one year of achievement of chemotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
change of functional learning test (WAIS)
Time Frame: 1 month after chemotherapy termination
1 month after chemotherapy termination
change of functional learning test (WAIS)
Time Frame: 12 months after one year of achievement of chemotherapy
12 months after one year of achievement of chemotherapy
change of depression scale
Time Frame: 1 month after chemotherapy termination
1 month after chemotherapy termination
change of depression scale
Time Frame: 12 months after one year of achievement of chemotherapy
12 months after one year of achievement of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Anne Julian, MD PhD, University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

September 29, 2015

First Submitted That Met QC Criteria

November 9, 2015

First Posted (Estimate)

November 10, 2015

Study Record Updates

Last Update Posted (Estimate)

November 10, 2015

Last Update Submitted That Met QC Criteria

November 9, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09 154 02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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