UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014594
Receipt number R000016979
Scientific Title Optimization of the scan timing after Gd contrast media injection in the detection of brain metastases-Multicenter study-
Date of disclosure of the study information 2014/09/01
Last modified on 2021/07/23 11:37:22

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Basic information

Public title

Optimization of the scan timing after Gd contrast media injection in the detection of brain metastases-Multicenter study-

Acronym

The optimal interval after Gd injection for MRI of brain metastases

Scientific Title

Optimization of the scan timing after Gd contrast media injection in the detection of brain metastases-Multicenter study-

Scientific Title:Acronym

The optimal interval after Gd injection for MRI of brain metastases

Region

Japan


Condition

Condition

Brain metastases

Classification by specialty

Radiology Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the optimal timing of image acquisition for the detection of lesions by retrospectively reviewing contrast-enhanced MRI images of metastatic brain tumors and by assessing changes in the lesion detection rate and in the signal intensity ratio against the surrounding brain parenchyma in function of the latency time between injection and imaging.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Phase IV


Assessment

Primary outcomes

The detection rate of metastatic brain tumor by subjective evaluation of images

Key secondary outcomes

The signal intensity ratio of metastatic brain tumor against the surrounding brain parenchyma


Base

Study type

Observational


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who meet all the following criteria can be included in the study
1) Patients who had undergone Gd-enhanced brain MRI in the past 3 years (dose: 0.1 mmol/kg)
2) Patients who had undergone contrast-enhanced T1-weighted SE images more than once
3) The time between injection of contrast agent and imaging can be estimated by minutes
4) Lesion size: 3 to 20 mm
5) Both inpatient and outpatient
6) Aged 20 years or older

Key exclusion criteria

Patients who meet any of the following criteria are not eligible for the study
1) Patients with bleeding that may affect measurement of the signal intensity
2) The signal intensity cannot be measured
3) Patients with 10 or more lesions
4) Patients who have already enrolled in the present study

Target sample size

600


Research contact person

Name of lead principal investigator

1st name Aoki
Middle name
Last name Shigeki

Organization

Juntendo University Hospital

Division name

Department of Radiology

Zip code

113-8421

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo

TEL

03-5802-1230

Email

saoki@juntendo.ac.jp


Public contact

Name of contact person

1st name Kouhei
Middle name
Last name Kamiya

Organization

The University of Tokyo Hospital

Division name

Department of Radiology

Zip code

113-8655

Address

7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655

TEL

03-5800-8666

Homepage URL


Email

kkamiya-tky@umin.ac.jp


Sponsor or person

Institute

Juntendo University

Institute

Department

Personal name



Funding Source

Organization

Bayer Yakuhin, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Juntendo University Hospital

Address

113-8421 2-1-1 Hongo, Bunkyo-ku, Tokyo

Tel

03-5802-1230

Email

saoki@juntendo.ac.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

2014 Year 09 Month 01 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000016979

Publication of results

Published


Result

URL related to results and publications

http://jsmrm2020.umin.jp/program_04.pdf

Number of participants that the trial has enrolled

490

Results

In total, MR images from 490 patients were analyzed (1223 tumor nodules). The detection rate of lesions with diameter of 3-10 mm increased with the delay time, and reached to a plateau around 97.5% at the delay time of 8-10 minutes. Quantitative measure of lesion contrast did not reveal any significant dependence on the delay time.

Results date posted

2021 Year 07 Month 23 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

patients diagnosed with metastatic brain tumors and underwent contrast-enhanced brain MRI

Participant flow

Retrospective observational study.
Each participating institution registers case records that satisfy the following inclusion criteria; 1) clinically diagnosed as metastatic brain tumor, 2) contrast-enhanced MRI using standard dose of GBCA (0.1 mmol/kg) was acquired, 3) more than two series of 2D-SE T1-weighted images were acquired after GBCA administration, 4) the delay time between image acquisition and GBCA injection could be specified, 5) lesion diameters were within 3-20 mm, 6) over 20 years of age.

Adverse events

None

Outcome measures

The detection rate of metastatic brain tumor by subjective evaluation of images
The signal intensity ratio of metastatic brain tumor against the surrounding brain parenchyma

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 07 Month 08 Day

Date of IRB

2014 Year 05 Month 23 Day

Anticipated trial start date

2014 Year 09 Month 01 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Retrospective observation study


Management information

Registered date

2014 Year 07 Month 18 Day

Last modified on

2021 Year 07 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016979


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name