UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048586
Receipt number R000055358
Scientific Title Evaluation of the physiological change in knee articular structures with T1rho/T2 mapping: the difference between before and after the exercise, and the diurnal change
Date of disclosure of the study information 2022/08/10
Last modified on 2024/02/07 18:50:35

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Evaluation of the physiological change in knee articular structures using quantitative MRI analysis

Acronym

KAS-QMRI

Scientific Title

Evaluation of the physiological change in knee articular structures with T1rho/T2 mapping: the difference between before and after the exercise, and the diurnal change

Scientific Title:Acronym

KAS-T1rho/T2 mapping

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Radiology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Knee joint MRI T1rho and T2 mapping will be performed in healthy subjects to investigate whether changes in signal values occur before and after exercise and with daily activities, and to verify these mechanism.

Basic objectives2

Others

Basic objectives -Others

Knee joint MRI T1rho and T2 mapping will be performed in healthy subjects to investigate whether changes in signal values occur before and after exercise and with daily activities, and to verify these mechanism.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Knee joint MRI (T1rho mapping, T2 mapping)

Key secondary outcomes



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

Other

Interventions/Control_1

1. Healthy subjects are asked to do exercises (jump rope 20 times x 10 sets, repetitive side jump 20 seconds x 10 sets, bending and stretching exercise 10 times x 10 sets) and bed rest, and a knee joint MRI is taken before and after them. A washout period of at least one week will be provided between each examination day.
2. Healthy subjects are asked to spend in a lying position, sitting position, and standing position for a longer time (target of 4 hours or more), and a knee joint MRI will be taken at morning (8:00 to 9:00) and evening (16:00 to 17:00). A washout period of at least one week will be provided between each examination day.

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

30 years-old >=

Gender

Male and Female

Key inclusion criteria

Men and women aged 20 to 30 with written informed consent

Key exclusion criteria

1. People who have a history of knee joint injury, treatment, or surgery, or patients who have been pointed out to have some kind of abnormality.
2. Cases with some symptoms in the knee joint.
3. Cases where sports or exercise is prohibited or cannot be done for some reason, or for some reason, standing, sitting, or lying down is prohibited or impossible.
4. Cases corresponding to MRI contraindication.
5. Cases in which MRI artifacts are likely to appear and signal values are difficult to measure.
6. History of malignant tumor
7. Those who may be pregnant

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Keita
Middle name
Last name Nagawa

Organization

Saitama medical university

Division name

Radiology department

Zip code

1120003

Address

2-1-2, Kasuga, Royal Tower Kasuga 503, Bukyo, Tokyo

TEL

09053001203

Email

ldeso5rbdlayids9taiy@gmail.com


Public contact

Name of contact person

1st name Keita
Middle name
Last name Nagawa

Organization

Saitama medical university

Division name

Radiology department

Zip code

3500495

Address

38 Morohongou, Moroyama-machi, Iruma-gun, Saitama

TEL

049-276-1265

Homepage URL


Email

radmini@saitama-med.ac.jp


Sponsor or person

Institute

Saitama medical university

Institute

Department

Personal name



Funding Source

Organization

Saitama medical university

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Saitama medical university hospital

Address

38 Morohongou, Moroyama-machi, Iruma-gun, Saitama

Tel

049-276-1354

Email

hirb@saitama-med.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

2022 Year 08 Month 10 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

2022 Year 08 Month 05 Day

Date of IRB


Anticipated trial start date

2022 Year 11 Month 01 Day

Last follow-up date

2025 Year 03 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

2022 Year 08 Month 04 Day

Last modified on

2024 Year 02 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055358


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name