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

Application of Diffusion Weighted Magnetic Resonance Imaging Versus CT in Evaluation of the Effect of Treating Lung Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Lung Neoplasms
• Intervention / Treatment: Procedure: Diffusion Magnetic Resonance Imaging

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital
      • Contact: Zhang Jian, professor; Phone Number: +8629-84771132; Email: zhangjian19701@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Procedure: Diffusion Magnetic Resonance Imaging; 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; Other Names: DW-MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADC value	The correlation of ADC value in 1 day before initial chemotherapy with histologic type and grade of lung cancer	1 day before initial chemotherapy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in ADC value	Change from baseline in ADC value will be documented at date of first documented progression, assessed up to 12 months post initial chemotherapy.	At the date of first documented progression, assessed up to 12 months

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China
• Investigators: Principal Investigator: Zhang Jian, professor, Air Force Military Medical University, China

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): February 1, 2016

Study Registration Dates

• First Submitted: December 9, 2014
• First Submitted That Met QC Criteria: December 16, 2014
• First Posted (Estimate): December 19, 2014

Study Record Updates

• Last Update Posted (Estimate): December 23, 2014
• Last Update Submitted That Met QC Criteria: December 19, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Lung Neoplasms; diffusion weighted MRI; ADC value; treatment effect
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Body Weight
• Other Study ID Numbers: 2013C2014