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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000011771
Receipt No. R000013761
Scientific Title Diagnostic performance of contrast-enhanced CT, Diffusion-weighted MRI and FDG-PET in pleural thickening -Prospective study-
Date of disclosure of the study information 2013/09/16
Last modified on 2013/09/14

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Basic information
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
Condition Mesothelioma
Classification by specialty
Pneumology Chest surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
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).

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Saitama Medical University International Medical Center
Institute
Department

Funding Source
Organization Bayer Yakuhin, Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Japanese Society of Thoracic Radiology
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 埼玉医科大学国際医療センター(埼玉県)

Other administrative information
Date of disclosure of the study information
2013 Year 09 Month 16 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
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
Other related information

Management information
Registered date
2013 Year 09 Month 14 Day
Last modified on
2013 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013761

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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