UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053281 |
|---|---|
| Receipt number | R000053151 |
| Scientific Title | Quantitative evaluation using dynamic contrast enhancement MRI (using TWIST-vibe) for assessment of tumor aggressiveness in transitional prostate cancer |
| Date of disclosure of the study information | 2024/01/05 |
| Last modified on | 2024/01/05 22:12:27 |
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Basic information
Public title
Comparison study between quantitative evaluation using dynamic contrast enhancement MRI for assessment of tumor aggressiveness in transitional prostate cancer and gleason score of histopathological evaluation
Acronym
Comparison study between quantitative evaluation using DCE-MRI for assessment of tumor aggressiveness in transitional prostate cancer and gleason score of histopathological evaluation
Scientific Title
Quantitative evaluation using dynamic contrast enhancement MRI (using TWIST-vibe) for assessment of tumor aggressiveness in transitional prostate cancer
Scientific Title:Acronym
Quantitative evaluation using DCE-MRI (using TWIST-vibe) for assessment of tumor aggressiveness in transitional prostate cancer
Region
| Japan |
Condition
Condition
transitional prostate cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the potential of quantitative evaluation using dynamic contrast enhancement MRI for assessment of tumor aggressiveness in transitional prostate cancer, in comparison with Gleason score of histopathological evaluation
Basic objectives2
Others
Basic objectives -Others
Prostate MRI is assessment using PI-RADS(Prostate Imaging Reporting and Data System)
(ver 2.1).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Statistical correlation between dynamic contrast-enhanced MRI quantitative analysis parameters and Gleason score of histopathological evaluation.
Research period: from March 2021 to March 2023
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
| 90 | years-old | >= |
Gender
Male
Key inclusion criteria
Patients were over PSA 4.0ng/ml.
Patients with transitional prostate cancer
diagnosed by biopsy before performing dynamic contrast enhancement MRI.
Key exclusion criteria
Patients with transitional prostate cancer
diagnosed by biopsy before not performing dynamic contrast enhancement MRI.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mariko |
| Middle name | |
| Last name | Doai |
Organization
Kanazawa Medical University
Division name
Department of Radiology
Zip code
9200293
Address
1-1 Daigaku Uchinada Kahoku Ishikawa, Japan
TEL
076-286-2211
doaimari@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Doai |
Organization
Kanazawa Medical University
Division name
Department of Radiology
Zip code
9200293
Address
1-1 Daigaku Uchinada Kahoku Ishikawa, Japan
TEL
076-286-2211
Homepage URL
doaimari@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa 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
Kanazawa Medical University
Address
1-1 Daigaku Uchinada Kahoku Ishikawa, Japan
Tel
076-286-2211
doaimari@kanazawa-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
| 2024 | Year | 01 | Month | 05 | Day |
Related information
URL releasing protocol
Preparing for paper submission
Publication of results
Unpublished
Result
URL related to results and publications
DCE-MRI using TWIST-vibe cannot be usefulness in differentiating transient zone of prostate cancer
Number of participants that the trial has enrolled
42
Results
The all parameters of Tissue 4D (Ktrans, Kep, Ve, iAUC ) showed no significant differences positive between negative of prostate cancer , transition zone vs peripheral zone of prostate cancer, and transition zone or peripheral zone of prostate cancer between negative by biopsy (Mann-Whitney test).
The all parameters of Tissue 4D showed no significant differences among histological grades of prostate cancer (Jonkheere-Terpstra test).
Results date posted
| 2024 | Year | 01 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Forty-two patients with elevated prostate specific antigen (PSA) level ( >4ng/ml)underwent dynamic contrast-enhanced MRI
Participant flow
Of the 42 cases, 15 cases were evaluated as PI-RADS category 1 or 2, 2 cases were refused biopsy, and 2 cases were due to insufficient images, and a total of 19 cases were excluded.
Adverse events
none
Outcome measures
Mann-Whitney test was used for comparisons between positive and negative, transition zone vs peripheral zone of prostate cancer, and transition zone or peripheral zone of prostate cancer between negative by biopsy.
The Jonkheere-Terpstra test was used to correlate the histological grades of the tumors (Gleason score; 6 or less-low risk, 7 intermediate risk, 8 or more -high risk group).
P-values <0.05 were considered to indicate statistical significance.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study was to evaluate a quantitative analysis of dynamic contrast-enhanced MRI (DCE-MRI using TWIST-vibe) and statistical examinations of benign to
malignancy using quantitative parameters and malignancy evaluations of the Gleason score in transition zone of prostate cancer.
The all parameters of Tissue 4D (Ktrans, Kep, Ve, iAUC) showed no significant differences positive between negative of prostate cancer, transition zone between peripheral zone of prostate cancer, and transition zone or peripheral zone of prostate cancer between negative by biopsy (Mann-Whitney test).
The all parameters of Tissue 4D showed no significant differences among histological grades of prostate cancer (Jonkheere-Terpstra test).
Management information
Registered date
| 2024 | Year | 01 | Month | 05 | Day |
Last modified on
| 2024 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053151
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