Condition category
Cancer
Date applied
21/08/2012
Date assigned
05/09/2012
Last edited
30/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Jing Wang

ORCID ID

Contact details

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

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 measures

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

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
Xi’an
710032
China

Sponsor type

University/education

Website

http://www.xjhyx.com/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/03/2017: Plain English summary added.