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

NCT ID: NCT02320617

Last Updated: 2014-12-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-02-29

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.

Conditions

Lung Neoplasms

Keywords

Lung Neoplasms; diffusion weighted MRI; ADC value; treatment effect

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.)

Group Type: EXPERIMENTAL

Diffusion Magnetic Resonance Imaging

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Other Intervention Names

DW-MRI

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Air Force Military Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Jian Zhang

deputy director of department of respiratory medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhang Jian, professor

Role: PRINCIPAL_INVESTIGATOR

Air Force Military Medical University, China

Locations

Xijing Hospital

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Li Jie, master

Role: CONTACT

Phone: +8629-84771132

Email: 935895498@qq.com

Facility Contacts

Zhang Jian, professor

Role: primary

References

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.

Reference Type: RESULT

PMID: 18043361 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23893610 (View on PubMed)

Other Identifiers

2013C2014

Identifier Type: -

Identifier Source: org_study_id