Plain English Summary
Background and study aims
We are carrying out a study of 300 patients with the three most frequent categories of lymphoma (Hodgkin disease and non-Hodgkin disease [follicular lymphoma and diffuse large B-cell lymphoma]) to compare 64-slice multidetector computed tomography (MDCT 64) and positron emission tomography - computed tomography (PET/CT) in the initial staging of patients. Once the diagnosis is carried out using the assigned technique the most suitable treatment will be decided. This study will provide evidence to recommend the diagnostic technology more suited for each clinical situation. The aim of the economic evaluation is to assess the technologies benefits in relation to the costs in order to use resources efficiently.
Who can participate?
Lymphoma patients aged 18 or over from University Hospital La Princesa, University Hospital La Paz and Clinic University Hospital San Carlos.
What does the study involve?
Patients will be randomly allocated to either MDCT 64 or PET/CT to establish the disease staging and to carry out the lesions study.
What are the possible benefits and risks of participating?
There should be benefits in relation to a better accuracy of disease staging, resulting in a better treatment response. The risk of diagnostic imaging is related to the radiation dose.
Where is the study run from?
The study is led by the Radiodiagnostic Department of La Princesa Hospital in Madrid (Spain).
When is study starting and how long is it expected to run for?
The recruitment started in January 2012. Participants will be enrolled on the study for a period of two years. However, the study will extend beyond with 1-year follow-up of patients.
Who is funding the study?
Funding has been provided by public funds from Health Research Funding (Carlos III Institute).
Who is the main contact?
Dr Nieves Gómez León
ngomezl.hlpr@salud.madrid.org
Trial website
Contact information
Type
Scientific
Primary contact
Dr Nieves Gómez León
ORCID ID
Contact details
C/ Diego de León
62
Madrid
28006
Spain
ngomezl.hlpr@salud.madrid.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Evaluation of 64-slice Multidetector Computed Tomography (MDCT 64) technique vs PET/CT: A multicenter clinical study of patients with Hodgkin lymphoma, diffuse large B-cell lymphoma and follicular lymphoma
Acronym
Study hypothesis
PET/CT hybrid technique provides major accuracy in the initial staging and better precision in the extension study with regards to MDCT 64
Ethics approval
Foundation´s Research Committee of La Princesa Hospital and Clinical Research Ethics Committee of La Princesa Hospital (Madrid), May 2011
Study design
Prospective randomized comparative study. Cost-effectiveness study according to the Markov model to compare the different diagnostic techniques.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Hodgkin disease and non-Hodgkin disease (Follicular lymphoma and Diffuse Large B-cell lymphoma)
Intervention
Accuracy diagnostic of both techniques (64-slice Multidetector Computed Tomography (MDCT 64) technique vs Positron emission tomography - computed tomography) and treatment response obtained during the treatment (2nd, 3rd cycle) and at the end of the treatment (6th cycle).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Treatment response
2. Disease free survival rates
Secondary outcome measures
1. Diagnostic test number
2. Hospital stay
3. Unit costs
4. EQ-5D survey
Overall trial start date
01/01/2012
Overall trial end date
01/01/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18 years old or over
2. Patients diagnosed by histology of lymphoid neoplasia
3. No previous lymphoma treatment
4. No previous diagnostic technique of staging
5. Informed consent signed
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant exclusion criteria
1. Renal failure
2. AIDS infection
3. Granulomatous or inflammatory diseases (tuberculosis, sarcoidosis)
4. Performance status > 3
Recruitment start date
01/01/2012
Recruitment end date
01/01/2015
Locations
Countries of recruitment
Spain
Trial participating centre
C/ Diego de León, 62
Madrid
28006
Spain
Sponsor information
Organisation
Carlos III Institute of Economy and Competitiveness Ministry (Spain)
Sponsor details
Calle Madrid 126
Getafe
28903
Spain
ngomezl.hlpr@salud.madrid.org
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
La Princesa Hospital Foundation (Spain) ref: PI11/01800
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary