Application of Diffusion Weighted MRI Versus CT in Evaluation of the Effect of Treating Lung Cancer
1 other identifier
interventional
80
1 country
1
Brief Summary
The purpose of this study is to investigate the diagnostic accuracy of ADC value of diffusion weighted MRI in comparison of conventional treatment assessment criteria in evaluation of chemotherapy. Moreover, the investigators aim to clarify the correlation of ADC value with histologic type and grade of lung cancer and survival of patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 9, 2014
CompletedFirst Posted
Study publicly available on registry
December 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedDecember 23, 2014
December 1, 2014
11 months
December 9, 2014
December 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in ADC value
Change from baseline in ADC value in 4,8,12 weeks(every two cycles of chemotherapy) post initial treatment when compared with RECIST (based on the CT examination), thus it can be estimated that the accuracy of ADC value in evaluating chemotherapy.
4,8,12 weeks post initial chemotherapy
Secondary Outcomes (1)
ADC value
1 day before initial chemotherapy
Other Outcomes (1)
Change from baseline in ADC value
At the date of first documented progression, assessed up to 12 months
Study Arms (1)
DW-MRI group
EXPERIMENTALTo evaluate the efficacy of chemoradiotherapy in lung cancer patients by DW-MRI when compared with conventional imaging modalities(CT, ultrasound et al.)
Interventions
Diffusion weighted imaging (DWI) is a form of magnetic resonance imaging based upon measuring the random Brownian motion of water molecules within a voxel of tissue. The relationship between histology and diffusion is complex, however generally densely cellular tissues or those with cellular swelling exhibit lower diffusion coefficients, and thus diffusion is particularly useful in tumour characterisation
Eligibility Criteria
You may qualify if:
- Age: 18-75
- Patients have confirmed lung cancer by histopathological methods (fiber, bronchoscopy, lung biopsy, open chest biopsy, pleural effusion exfoliated cells, sputum exfoliated cells)
- After clinical assessment, patients who need chemotherapy (tumor stage III or IV of lung cancer or others who are reluctant to receive pneumonectomy);
- Patients have no previous history of chemotherapy
- Patients with at least one clearly measurable lung lesion (lesion size larger than 10mm, by spiral CT, according to RECIST)
- Health status scoring between 0-2 by Eastern Cooperative Oncology Group(ECOG) method
- Patients voluntarily to join this study and signed informed consents.
You may not qualify if:
- Any body metal implants (pacemaker implantation, nerve stimulator, vascular stent, aneurysm clip, eye foreign body, the inner metal prosthesis) or artificial heart valves
- Patients with claustrophobia to MRI or CT examination
- Patients who are reluctant to comply with follow-up and subsequent examination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xijing Hospital
Xi'an, Shaanxi, 710032, China
Related Publications (2)
Honda O, Tsubamoto M, Inoue A, Johkoh T, Tomiyama N, Hamada S, Mihara N, Sumikawa H, Natsag J, Nakamura H. Pulmonary cavitary nodules on computed tomography: differentiation of malignancy and benignancy. J Comput Assist Tomogr. 2007 Nov-Dec;31(6):943-9. doi: 10.1097/RCT.0b013e3180415e20.
PMID: 18043361RESULTZhang J, Cui LB, Tang X, Ren XL, Shi JR, Yang HN, Zhang Y, Li ZK, Wu CG, Jian W, Zhao F, Ti XY, Yin H. DW MRI at 3.0 T versus FDG PET/CT for detection of malignant pulmonary tumors. Int J Cancer. 2014 Feb 1;134(3):606-11. doi: 10.1002/ijc.28394. Epub 2013 Sep 16.
PMID: 23893610RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhang Jian, professor
Air Force Military Medical University, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- deputy director of department of respiratory medicine
Study Record Dates
First Submitted
December 9, 2014
First Posted
December 19, 2014
Study Start
December 1, 2014
Primary Completion
November 1, 2015
Study Completion
February 1, 2016
Last Updated
December 23, 2014
Record last verified: 2014-12