NCT02601547

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable lymphoma

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 10, 2015

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

Enrollment Period

2.5 years

First QC Date

September 29, 2015

Last Update Submit

November 9, 2015

Conditions

Lymphoma

Keywords

Positron-Emission Tomographychemotherapy-induced brain damageneuro-cognitive function alteration

Outcome Measures

Primary Outcomes (2)

  • Change of Standard Uptake Value

    1 month after chemotherapy termination

  • Change of Standard Uptake Value

    12 months after one year of achievement of chemotherapy

Secondary Outcomes (4)

  • change of functional learning test (WAIS)

    1 month after chemotherapy termination

  • change of functional learning test (WAIS)

    12 months after one year of achievement of chemotherapy

  • change of depression scale

    1 month after chemotherapy termination

  • change of depression scale

    12 months after one year of achievement of chemotherapy

Study Arms (1)

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.

Device: PET-FDG brain imaging and NPT

Interventions

PET-FDG brain imaging and NPTDEVICE

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.

Also known as: 18F-Fluoro-Desoxy-Glucose brain imaging and NPT
intervention

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Toulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Anne Julian, MD PhD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2015

First Posted

November 10, 2015

Study Start

September 1, 2010

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

November 10, 2015

Record last verified: 2015-11

Locations

FR(1)