Comparison of DWI-MRI and 18F-FDG PET/CT whole body scans in the diagnosis of tumors

ISRCTN ISRCTN72560777
DOI https://doi.org/10.1186/ISRCTN72560777
Protocol serial number 2012-08-DWI; 2012-08-FDG
Sponsor Fourth Military Medical University (China)
Funder Xijing Hospital (China)
Submission date
21/08/2012
Registration date
05/09/2012
Last edited
30/03/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Prof Jing Wang
Scientific

Fourth Military Medical University
127 West Changle Road
Xi'an
710032
China

Study information

Primary study designInterventional
Study designProspective randomized blinded controlled study
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleComparison of the efficacy of DWI-MRI and 18F-FDG PET/CT whole body scans in the diagnosis of tumors: a multicenter clinical study
Study objectivesDWI (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(s)Not provided at time of regsitration
Health condition(s) or problem(s) studiedBrain, lung, liver and pancreatic tumor including T, N and M staging.
InterventionInjection 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 typeOther
Primary outcome measure(s)

1. 18F-FDG PET/CT: the number of lesion, SUV
2. DWI-MRI: the number of lesion, ADC

Key secondary outcome measure(s)

1. 18F-FDG PET/CT: tumor volume, TLG (suv evolume)
2. DWI-MRI: tumor volume and size (max long axial)

Completion date30/03/2013

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit80 Years
SexAll
Target sample size at registration150
Key inclusion criteriaBrain, 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
Key exclusion criteria1. Withdrawal of informed consent
2. Without pathology result
3. Against research programme
Date of first enrolment30/08/2012
Date of final enrolment30/03/2013

Locations

Countries of recruitment

  • China

Study participating centre

Fourth Military Medical University
Xi'an
710032
China

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

30/03/2017: Plain English summary added.