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

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02320617
• Other study ID #: 2013C2014
• Status: Recruiting
• Phase: N/A
• First received: December 9, 2014
• Last updated: December 19, 2014
• Start date: December 2014
• Est. completion date: February 2016

Study information

• Verified date: December 2014
• Source: Fourth Military Medical University
• Contact: Li Jie, master
• Phone: +8629-84771132
• Email: 935895498[@]qq.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

References & 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No