UMIN-CTR Clinical Trial

Public title

Diagnostic performance of contrast-enhanced CT, Diffusion-weighted MRI and FDG-PET in pleural thickening -Prospective study-

Acronym

Diagnostic performance of contrast-enhanced CT, Diffusion-weighted MRI and FDG-PET in pleural thickening -Prospective study-

Scientific Title

Diagnostic performance of contrast-enhanced CT, Diffusion-weighted MRI and FDG-PET in pleural thickening -Prospective study-

Scientific Title:Acronym

Diagnostic performance of contrast-enhanced CT, Diffusion-weighted MRI and FDG-PET in pleural thickening -Prospective study-

Region

Japan

Condition

Mesothelioma

Classification by specialty

Pneumology	Chest surgery	Radiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The study is conducted with an aim to prospectively examine the usefulness of contrasted CT, diffusion-weighted MRI, and FDG-PET in differentiating diffuse mesothelioma from non-neoplastic pleural thickening such as fibrous pleurisy.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV

Primary outcomes

The overall abilities (sensitivity, specificity, and accuracy) to diagnose mesothelioma, disseminated lung cancer, and benign pleural disease (e.g., pleurisy) of various modalities (i.e., contrasted CT, DWI-MRI, and FDG-PET) are compared with those from definite diagnosis.

Key secondary outcomes

•Characteristic appearances are examined for mesothelioma, disseminated lung cancer, and benign pleural disease (pleurisy).
• Diagnostic performance (sensitivity, specificity, and accuracy) is compared among various modalities (i.e., contrasted CT, DWI-MRI, and FDG-PET).

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Device,equipment

Interventions/Control_1

Patients suspected of having clinical sign of mesothelioma are prospectively enrolled, and these patients will undergo CT-based (plain CT and contrasted CT), MRI-based (T1WI, T2WI, DWI, and contrasted T1WI), and FDG-PET-based examinations in the next 6 weeks.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients who have recurrence pleural fluid of unknown cause and/or pleural thickening of unknown cause, and indefinite diagnosis of malignant tumor lung cancer or mesothelioma by diagnostic imaging and/or thoracentesis.
2) Both inpatients and outpatients
3) Both men and women
4) Patients aged 20 years or older
5) Patients who had been provided with ample explanation before participating in this clinical study, fully understood the content of the study, and submitted a written consent to voluntarily participate in the study

Key exclusion criteria

1) Patients in whom pathological diagnosis was made
2) Patients who underwent invasive treatment
3) Patients for whom the investigator or subinvestigator(s) judges their participation in the clinical trial to be inappropriate
4) Patients in whom MRI examination is contraindicated (e.g., use of a pacemaker)
5) Patients in whom iodine-based and Gd-based contrast media are contraindicated (e.g., patients with a history of hypersensitivity to these contrast media)

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Fumikazu Sakai

Organization

Saitama Medical University International Medical Center

Division name

Department of Diagnostic Radiology

Zip code

Address

1397-1 Yamane Hidaka-shi, Saitama, Japan

TEL

042-984-4520

Email

fmksakai@yahoo.co.jp

Name of contact person

1st name
Middle name
Last name	Fumikazu Sakai

Organization

Saitama Medical University International Medical Center

Division name

Department of Diagnostic Radiology

Zip code

Address

1397-1 Yamane Hidaka-shi, Saitama, Japan

TEL

042-984-4520

Homepage URL

Email

fmksakai@yahoo.co.jp

Institute

Saitama Medical University International Medical Center

Institute

Department

Personal name

Organization

Bayer Yakuhin, Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Japanese Society of Thoracic Radiology

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

埼玉医科大学国際医療センター(埼玉県）

Date of disclosure of the study information

2013

Year

09

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2013

Year

04

Month

01

Day

Date of IRB

Anticipated trial start date

2013

Year

09

Month

16

Day

Last follow-up date

2018

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

09

Month

14

Day

Last modified on

2013

Year

09

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013761