UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000062164
Receipt number R000071140
Scientific Title A prospective observational study on the correlation between changes in ADC values on diffusion-weighted MRI (DWI) and tumor shrinkage before and after stereotactic body radiotherapy (SBRT) for lung cancer
Date of disclosure of the study information 2026/07/07
Last modified on 2026/07/07 17:56:49

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Basic information

Public title

A prospective observational study on the correlation between changes in ADC values on diffusion-weighted MRI (DWI) and tumor shrinkage before and after stereotactic body radiotherapy (SBRT) for lung cancer

Acronym

A prospective observational study on the correlation between changes in ADC values on diffusion-weighted MRI (DWI) and tumor shrinkage before and after stereotactic body radiotherapy (SBRT) for lung cancer

Scientific Title

A prospective observational study on the correlation between changes in ADC values on diffusion-weighted MRI (DWI) and tumor shrinkage before and after stereotactic body radiotherapy (SBRT) for lung cancer

Scientific Title:Acronym

A prospective observational study on the correlation between changes in ADC values on diffusion-weighted MRI (DWI) and tumor shrinkage before and after stereotactic body radiotherapy (SBRT) for lung cancer

Region

Japan


Condition

Condition

Lung cancer

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To find out the outcome of radiotehrapy for lung cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Disapearance of tumor on MRI

Key secondary outcomes



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

99 years-old >

Gender

Male and Female

Key inclusion criteria

The patients with written informed consent

Key exclusion criteria

N/A

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Osamu
Middle name University
Last name Tanaka

Organization

Asahi Univerisity

Division name

Department of Radiation Oncology

Zip code

5008523

Address

Gifu city

TEL

0582538001

Email

c.bluered@gmail.com


Public contact

Name of contact person

1st name Osamu
Middle name
Last name Tanaka

Organization

Asahi Univeristy

Division name

Department of Radiation Oncology

Zip code

5008523

Address

3-23 Hashimoto-Cho, Gufy city, Gifu

TEL

0582538001

Homepage URL


Email

c.bluered@gmail.com


Sponsor or person

Institute

Asahi Univeristy

Institute

Department

Personal name

Osamu Tanaka


Funding Source

Organization

Asahi Univeristy

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Asahi University

Address

3-23 Hashimoto-Cho, Gufy city, Gifu

Tel

0582538001

Email

c.bluered@gmail.com


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW

岐阜県


Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2026 Year 07 Month 07 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

Open public recruiting

Date of protocol fixation

2020 Year 03 Month 04 Day

Date of IRB

2022 Year 06 Month 16 Day

Anticipated trial start date

2022 Year 01 Month 04 Day

Last follow-up date

2029 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

No


Management information

Registered date

2026 Year 07 Month 07 Day

Last modified on

2026 Year 07 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071140