Plain English Summary
Background and study aims:
There are different types of medical scans that can be used to diagnose tumours (a mass of cells). Diffusion weighted imaging- magnetic resonance imaging (DWI-MRI) is a type of scan that uses the changes of water movement to create an image. 18F-fluorodeoxyglucose Positron Emission Tomography (18F-FDG PET) is a type of scan that uses a small amount of a drug as a tracer (FDG) to show the difference between healthy tissue and diseased tissue. These two different scans show tumour in different ways. Some researchers think DWI-MRI scans can replace 18F-FDG PET scans for diagnosing tumours and that 18F-FDG PET should only be used for certain types of cancers. The aim of this study is to compare different types of imaging to see which one has the best clinical outcomes for diagnosing tumours.
Who can participate?
Adults aged 18-80 who have brain, lung, liver and pancreatic tumour.
What does the study involve?
Participants undergo their standard scan using the 18F-FDG PET/CT scan or the DWI-MRI. Each scan is assessed to see how well it can diagnose tumours.
What are the possible benefits and risks of participating?
There are no notable benefits or risks with participating.
Where is the study run from?
Fourth Military Medical University (China)
When is study starting and how long is it expected to run for?
August 2012 to March 2013
Who is funding the study?
Xijing Hospital (China)
Who is the main contact?
Prof Jing Wang
wangjing@fmmu.edu.cn
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2012-08-DWI; 2012-08-FDG
Study information
Scientific title
Comparison of the efficacy of DWI-MRI and 18F-FDG PET/CT whole body scans in the diagnosis of tumors: a multicenter clinical study
Acronym
Study hypothesis
DWI (Diffusion weighted imaging, WI) and 18F-FDG PET/CT different imaging mechanism, comparison of DWI-MRI and 18F-FDG PET/CT whole body scan in the diagnosis of tumor efficacy and to find out the best clinical indications. Choice in different city 9 PET/CT center participated in the study.
Ethics approval
Not provided at time of regsitration
Study design
Prospective randomized blinded controlled study
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
Brain, lung, liver and pancreatic tumor including T, N and M staging.
Intervention
Injection FDG accoring to mCi/KG. The research focus is to find DWI-MR and FDG PET/CT, as well as how to play their respective advantages in clinical.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. 18F-FDG PET/CT: the number of lesion, SUV
2. DWI-MRI: the number of lesion, ADC
Secondary outcome measures
1. 18F-FDG PET/CT: tumor volume, TLG (suv evolume)
2. DWI-MRI: tumor volume and size (max long axial)
Overall trial start date
30/08/2012
Overall trial end date
30/03/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Brain, lung, liver and pancreatic tumor including T, N and M staging.
1. Age of 18 - 80 years
2. Clinical pathology in patients with brain, lung, liver and pancreaticcancer
3. Patients without radiotherapy, chemotherapy
4. DWI and 18F-FDG PET/CT scanning in the same week
5. DWI and 18F-FDG PET/CT scanning sequence is random
6. Volunteered to participate in and signed informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
More than 150 cases
Participant exclusion criteria
1. Withdrawal of informed consent
2. Without pathology result
3. Against research programme
Recruitment start date
30/08/2012
Recruitment end date
30/03/2013
Locations
Countries of recruitment
China
Trial participating centre
Fourth Military Medical University
Xi'an
710032
China
Sponsor information
Organisation
Fourth Military Medical University (China)
Sponsor details
c/o Prof Jing Wang
127 West Changle Road
Xian
710032
China
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Xijing Hospital (China)
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
Basic results (scientific)
Publication list