Condition category
Cancer
Date applied
22/05/2012
Date assigned
03/08/2012
Last edited
04/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes