Evaluation of 64-slice Multidetector Computed Tomography (MDCT 64) technique vs Positron emission tomography - computed tomography (PET/CT)
| ISRCTN | ISRCTN79508741 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79508741 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/05/2012
- Registration date
- 03/08/2012
- Last edited
- 29/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
C/ Diego de León, 62
Madrid
28006
Spain
| ngomezl.hlpr@salud.madrid.org |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | Foundation´s Research Committee of La Princesa Hospital and Clinical Research Ethics Committee of La Princesa Hospital (Madrid), May 2011 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2012 |
| Completion date | 01/01/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 300 |
| Total final enrolment | 72 |
| Key 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 |
| Key exclusion criteria | 1. Renal failure 2. AIDS infection 3. Granulomatous or inflammatory diseases (tuberculosis, sarcoidosis) 4. Performance status > 3 |
| Date of first enrolment | 01/01/2012 |
| Date of final enrolment | 01/01/2015 |
Locations
Countries of recruitment
- Spain
Study participating centre
28006
Spain
Sponsor information
Hospital/treatment centre
Calle Madrid 126
Getafe
28903
Spain
| ngomezl.hlpr@salud.madrid.org |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 12/10/2018 | 29/05/2020 | Yes | No |
Editorial Notes
29/05/2020: Publication reference and total final enrolment number added.
