LymphomaLYMCOTEPNCT02601547
PET-based Evaluation of Chemotherapy-induced Brain Damage in Lymphoma
A study testing PET-FDG brain imaging and NPT in people with Lymphoma, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- PET-FDG brain imaging and NPT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- speaking well French language
- benefiting from general medical insurance
- registered in the national listing of patients for biomedical research.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lymphoma
- Being tested
- PET-FDG brain imaging and NPT
- Keywords
- Positron-Emission Tomography, chemotherapy-induced brain damage, neuro-cognitive function alteration
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-FDG brain imaging and NPTDevice
Also called 18F-Fluoro-Desoxy-Glucose 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.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | 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. Receives: Device: PET-FDG brain imaging and NPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Standard Uptake Value
Measured: 1 month after chemotherapy termination
Change of Standard Uptake Value
Measured: 12 months after one year of achievement of chemotherapy
Secondary outcomes (4)
change of functional learning test (WAIS)
Measured: 1 month after chemotherapy termination
change of functional learning test (WAIS)
Measured: 12 months after one year of achievement of chemotherapy
change of depression scale
Measured: 1 month after chemotherapy termination
change of depression scale
Measured: 12 months after one year of achievement of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startSep 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Julian, MD PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601547
- Sponsor's protocol ID
- 09 154 02
- Acronym
- LYMCOTEP
- Status last verified
- Nov 2015
- First submitted
- 29 Sep 2015
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET-based Evaluation of Chemotherapy-induced Brain Damage in Lymphoma Patients -Implication in the Evaluation of Neuro-cognitive Function Alteration (LYMCOTEP)
- ClinicalTrials.gov ID
- NCT02601547
- Acronym / sponsor ID
- LYMCOTEP / 09 154 02
- Conditions
- Lymphoma
- Keywords
- Positron-Emission Tomography, chemotherapy-induced brain damage, neuro-cognitive function alteration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 10 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Device: PET-FDG brain imaging and NPT1. 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET-FDG brain imaging and NPTAlso: 18F-Fluoro-Desoxy-Glucose brain imaging and NPTPET-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. | Device | intervention |
Primary outcome
Change of Standard Uptake Value
Time frame: 1 month after chemotherapy termination
Change of Standard Uptake Value
Time frame: 12 months after one year of achievement of chemotherapy
4 secondary outcomes
change of functional learning test (WAIS)
Time frame: 1 month after chemotherapy termination
change of functional learning test (WAIS)
Time frame: 12 months after one year of achievement of chemotherapy
change of depression scale
Time frame: 1 month after chemotherapy termination
change of depression scale
Time frame: 12 months after one year of achievement of chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Julian, MD PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET-FDG brain imaging and NPT in people with Lymphoma, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Standard Uptake Value (time frame: 1 month after chemotherapy termination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2015.