UMIN-ICDS Clinical Trial

Public title

A Study of Advanced Diffusion MRI for Improving the Diagnosis of Prostate Cancer

Acronym

Prostate IMPULSED MRI Study

Scientific Title

Evaluation of the Utility of IMPULSED Diffusion MRI on the Advanced MRI System MAGNETOM Cima.X for Improving the Diagnostic Accuracy of Prostate Cancer MRI

Scientific Title:Acronym

Prostate IMPULSED Study

Region

Japan

Condition

Prostate cancer or suspected prostate cancer

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate the associations of IMPULSED-derived microstructural parameters obtained from time-dependent diffusion MRI using a high-performance 3-T MRI system with pathological tumor grade, conventional MRI findings, and clinical characteristics in prostate cancer, and to explore the utility of IMPULSED analysis for detecting clinically significant prostate cancer and assessing tumor aggressiveness.

Basic objectives2

Others

Basic objectives -Others

Exploration of the diagnostic utility of IMPULSED-derived microstructural parameters and their associations with pathological tumor grade in prostate cancer

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Associations between IMPULSED-derived microstructural parameters and pathological tumor grade in participants with available pathological results after MRI. Cell diameter, intracellular volume fraction, cellularity index, and extracellular diffusion coefficient derived from IMPULSED will be evaluated in relation to Gleason score, ISUP grade group, and the presence of clinically significant prostate cancer.

Key secondary outcomes

1. Associations between IMPULSED-derived microstructural parameters and conventional MRI findings assessed after MRI, including PI-RADS category, apparent diffusion coefficient values, diffusion-weighted imaging findings, and T2-weighted imaging findings.
2. Associations between IMPULSED-derived microstructural parameters and clinical characteristics, including prostate-specific antigen level, prostate-specific antigen density, prostate volume, clinical stage, treatment history, treatment type, and clinical course.
3. Associations between IMPULSED-derived microstructural parameters and findings from other imaging examinations, including PSMA PET/CT, in participants for whom such examinations are available.
4. Image quality of time-dependent diffusion MRI and stability of IMPULSED analysis, assessed using image quality, image distortion, signal loss, the proportion and causes of unsuccessful or difficult analyses, and reproducibility of the measured parameters.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No need to know

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

All participants will undergo non-contrast time-dependent diffusion MRI using the high-performance 3-T MRI system MAGNETOM Cima.X.

For participants undergoing clinically indicated prostate MRI, approximately 5 minutes of time-dependent diffusion MRI will be added immediately after the standard prostate MRI during the same examination session.

For participants who have already undergone clinically indicated prostate MRI at another institution or elsewhere and for whom repeat clinical prostate MRI at the study institution is considered unnecessary, non-contrast MRI consisting of basic prostate images required for research analysis and time-dependent diffusion MRI will be performed for approximately 10 minutes, principally during hospitalization.

No contrast agent, other investigational medication, blood sampling, or tissue sampling will be performed solely for this study.

If a participant undergoes clinically indicated prostate MRI more than once during the study period for treatment response assessment or follow-up, approximately 5 minutes of time-dependent diffusion MRI may be added at each clinically indicated MRI examination. Research MRI will not be repeated solely for the purpose of acquiring time-dependent diffusion MRI.

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male

Key inclusion criteria

1. Male participants aged 20 years or older
2. Participants with suspected prostate cancer or those considered to require prostate MRI for the diagnosis of prostate cancer, treatment planning, treatment response assessment, or follow-up
3. Participants who meet either of the following conditions:
Those scheduled to undergo clinically indicated prostate MRI at the study institution and able to undergo additional time-dependent diffusion MRI during the standard MRI examination
Those who have already undergone clinically indicated prostate MRI, whose images are available for clinical use at the study institution, and for whom repeat clinical prostate MRI is considered unnecessary by the treating physician, but who are able to undergo research MRI during hospitalization
4. Participants who provide written informed consent to participate in the study

Key exclusion criteria

1. Participants who do not provide written informed consent
2. Participants younger than 20 years
3. Participants for whom MRI is contraindicated or considered inappropriate
4. Participants whose imaging data are considered unsuitable for analysis because of motion, metal-related artifacts, severe image distortion, interrupted image acquisition, or other causes
5. Participants considered unsuitable for participation by the principal investigator or a study investigator

Target sample size

50

Name of lead principal investigator

1st name	Kota
Middle name
Last name	Yokoyama

Organization

Institute of Science Tokyo

Division name

Diagnostic Radiology and Nuclear Medicine

Zip code

113-8510

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan

TEL

03-5803-5311

Email

ykymdrnm@tmd.ac.jp

Name of contact person

1st name	Yusuke
Middle name
Last name	Kawasaki

Organization

Institute of Science Tokyo

Division name

Diagnostic Radiology and Nuclear Medicine

Zip code

113-8510

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan

TEL

03-5803-5311

Homepage URL

Email

kwskdrnm@tmd.ac.jp

Institute

Institute of Science Tokyo

Institute

Department

Personal name

Kota Yokoyama

Organization

Siemens Healthineers

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Medical Research Ethics Committee, Institute of Science Tokyo

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8510, Japan

Tel

03-5803-4547

Email

rinri.adm@tmd.ac.jp

Secondary IDs

YES

Study ID_1

I2026-133

Org. issuing International ID_1

Medical Research Ethics Committee, Institute of Science Tokyo

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京科学大学病院（東京都）

Date of disclosure of the study information

2026

Year

07

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

07

Month

23

Day

Date of IRB

Anticipated trial start date

2026

Year

08

Month

17

Day

Last follow-up date

2031

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

07

Month

31

Day

Last modified on

2026

Year

07

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071434