UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000054995
Receipt number R000062833
Scientific Title The advantage of Dual-energy CT for diagnosing pulmonary embolism: a systematic review and meta-analysis
Date of disclosure of the study information 2024/07/17
Last modified on 2024/07/17 15:53:08

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Basic information

Public title

The advantage of Dual-energy CT for diagnosing pulmonary embolism: a systematic review and meta-analysis

Acronym

The advantage of Dual-energy CT for diagnosing pulmonary embolism: a systematic review and meta-analysis

Scientific Title

The advantage of Dual-energy CT for diagnosing pulmonary embolism: a systematic review and meta-analysis

Scientific Title:Acronym

The advantage of Dual-energy CT for diagnosing pulmonary embolism: a systematic review and meta-analysis

Region

Japan


Condition

Condition

pulmonary embolism, chronic thromboembolic pulmonary hypertension

Classification by specialty

Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to demonstrate the advantage of dual-energy computed tomography (CT) for diagnosing pulmonary embolism and relevant conditions, such as chronic thromboembolic pulmonary hypertension.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The sensitivity and specificity (diagnostic accuracy) for the diagnosis of pulmonary embolism by using dual-energy CT

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patient: Patients who were suspected to have pulmonary embolism and relevant conditions (i.e. chronic thromboembolic pulmonary hypertension: CTEPH) and underwent perfusion CT scans by dual-energy CT scanners
Paper: English papers only

Key exclusion criteria

Patient: N/A
Paper: Not written in English, case report, abstract for academic conference

Target sample size



Research contact person

Name of lead principal investigator

1st name Tsuneo
Middle name
Last name Yamashiro

Organization

Yokohama City University

Division name

Department of Radiology

Zip code

236-0004

Address

3-9 Fukuura, Kanazawa-ku, Yokohama

TEL

0457872696

Email

clatsune@yahoo.co.jp


Public contact

Name of contact person

1st name Tsuneo
Middle name
Last name Yamashiro

Organization

Yokohama City University

Division name

Department of Radiology

Zip code

236-0004

Address

3-9 Fukuura, Kanazawa-ku, Yokohama

TEL

0457872696

Homepage URL


Email

clatsune@yahoo.co.jp


Sponsor or person

Institute

Yokohama City University

Institute

Department

Personal name



Funding Source

Organization

Yokohama City University

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Yokohama City University, Institutional Review Board

Address

3-9 Fukuura, Kanazawa-ku, Yokohama

Tel

0457872696

Email

clatsune@yahoo.co.jp


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



Other administrative information

Date of disclosure of the study information

2024 Year 07 Month 17 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

Enrolling by invitation

Date of protocol fixation

2024 Year 07 Month 16 Day

Date of IRB

2024 Year 07 Month 17 Day

Anticipated trial start date

2024 Year 07 Month 17 Day

Last follow-up date

2027 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is a systematic review/meta-analysis for searching the advantage of dual-energy CT for diagnosing pulmonary embolism and relevant conditions.
Primary endpoint: sensitivity, specificity
Secondary endpoint: AUC, diagnostic odds ratio


Management information

Registered date

2024 Year 07 Month 17 Day

Last modified on

2024 Year 07 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062833


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name