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Application of Diffusion Weighted MRI Versus CT in Evaluation of the Effect of Treating Lung Cancer

Primary Purpose

Lung Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Diffusion Magnetic Resonance Imaging
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Neoplasms focused on measuring Lung Neoplasms, diffusion weighted MRI, ADC value, treatment effect

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age: 18-75
  2. Patients have confirmed lung cancer by histopathological methods (fiber, bronchoscopy, lung biopsy, open chest biopsy, pleural effusion exfoliated cells, sputum exfoliated cells)
  3. After clinical assessment, patients who need chemotherapy (tumor stage III or IV of lung cancer or others who are reluctant to receive pneumonectomy);
  4. Patients have no previous history of chemotherapy
  5. Patients with at least one clearly measurable lung lesion (lesion size larger than 10mm, by spiral CT, according to RECIST)
  6. Health status scoring between 0-2 by Eastern Cooperative Oncology Group(ECOG) method
  7. Patients voluntarily to join this study and signed informed consents.

Exclusion Criteria:

  1. Any body metal implants (pacemaker implantation, nerve stimulator, vascular stent, aneurysm clip, eye foreign body, the inner metal prosthesis) or artificial heart valves
  2. Patients with claustrophobia to MRI or CT examination
  3. Patients who are reluctant to comply with follow-up and subsequent examination
  4. The other condition that do not meet the inclusion criteria.

Sites / Locations

  • Xijing HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DW-MRI group

Arm Description

To evaluate the efficacy of chemoradiotherapy in lung cancer patients by DW-MRI when compared with conventional imaging modalities(CT, ultrasound et al.)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

ADC value
The correlation of ADC value in 1 day before initial chemotherapy with histologic type and grade of lung cancer

Full Information

First Posted
December 9, 2014
Last Updated
December 19, 2014
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT02320617
Brief Title
Application of Diffusion Weighted MRI Versus CT in Evaluation of the Effect of Treating Lung Cancer
Official Title
Application of Diffusion Weighted Magnetic Resonance Imaging Versus CT in Evaluation of the Effect of Treating Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
February 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
In recent years, lung cancer is an aggressive and heterogeneous disease, Advances in surgical and chemotherapeutic approaches have been made, but the long-term survival rate remains low. Although effective mass screening of high-risk groups could potentially be of benefit, randomized trials of screening with the use of chest radiography with or without cytological analysis of sputum specimens have shown no reduction in lung-cancer mortality. Currently, Response Evaluation Criteria in Solid Tumors (RECIST) by CT is the most commonly used to evaluate chemotherapy of lung cancer patient, but patients have to be exposed to radiation. For this reason, the investigators aim to assess the diagnostic accuracy of apparent diffusion coefficient (ADC) value, a specific parameter of radiation-free diffusion weighted MRI, in comparison of RECIST, and its correlation with histologic type and grade of lung cancer as well. Furthermore, the investigators investigate its correlation with Progression Free Survival (PFS) and Overall Survival (OS) in patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms
Keywords
Lung Neoplasms, diffusion weighted MRI, ADC value, treatment effect

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DW-MRI group
Arm Type
Experimental
Arm Description
To evaluate the efficacy of chemoradiotherapy in lung cancer patients by DW-MRI when compared with conventional imaging modalities(CT, ultrasound et al.)
Intervention Type
Procedure
Intervention Name(s)
Diffusion Magnetic Resonance Imaging
Other Intervention Name(s)
DW-MRI
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline in ADC value
Description
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.
Time Frame
4,8,12 weeks post initial chemotherapy
Secondary Outcome Measure Information:
Title
ADC value
Description
The correlation of ADC value in 1 day before initial chemotherapy with histologic type and grade of lung cancer
Time Frame
1 day before initial chemotherapy
Other Pre-specified Outcome Measures:
Title
Change from baseline in ADC value
Description
Change from baseline in ADC value will be documented at date of first documented progression, assessed up to 12 months post initial chemotherapy.
Time Frame
At the date of first documented progression, assessed up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 The other condition that do not meet the inclusion criteria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Jie, master
Phone
+8629-84771132
Email
935895498@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhang Jian, professor
Organizational Affiliation
Air Force Military Medical University, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Jian, professor
Phone
+8629-84771132
Email
zhangjian19701@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
18043361
Citation
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.
Results Reference
result
PubMed Identifier
23893610
Citation
Zhang 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.
Results Reference
result

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Application of Diffusion Weighted MRI Versus CT in Evaluation of the Effect of Treating Lung Cancer

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