UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050336 |
|---|---|
| Receipt number | R000057315 |
| Scientific Title | Prediction of motor recovery in postoperative brain tumors using diffusion tensor imaging and regional cerebral blood flow |
| Date of disclosure of the study information | 2023/02/14 |
| Last modified on | 2023/02/14 15:24:25 |
* 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
Prediction of motor recovery in postoperative brain tumors using imaging studies
Acronym
Trial of predicting motor recovery
Scientific Title
Prediction of motor recovery in postoperative brain tumors using diffusion tensor imaging and regional cerebral blood flow
Scientific Title:Acronym
Prediction of motor recovery in postoperative brain tumors using diffusion tensor imaging and regional cerebral blood flow
Region
| Japan |
Condition
Condition
Brain tumors
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the relationship between Diffusion Tensor Imaging (DTI) and regional Cerebral Blood Flow (rCBF) and motor outcomes before and after surgery in patients with supratentorial brain tumors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluated motor function in patients with brain tumors using the Manual Muscle Test (MMT) on admission and at discharge. DTI parameters in the corticospinal tract (CST) (cerebral peduncle, posterior limb of internal capsule, and corona radiata) on the DTI were compared between patients with and without preoperative motor paralysis. The rCBF in the CST on the DTI in both groups was also evaluated in the diseased/healthy and diseased/ipsilateral cerebellar hemispheres.
We examined the DTI index of CST on DTI and rCBF in the group with improved postoperative paralysis and the group with unchanged and worsened postoperative paralysis.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
84 patients with supratentorial brain tumors who underwent surgical treatment at Toho University Medical Center Omori Hospital at the period from January 2016 to June 2022, of whom DTI and SPECT could be taken before surgery, included in the study.
Key exclusion criteria
None
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Chie |
| Middle name | |
| Last name | Nakada |
Organization
Toho University Omori Medical Center, Tokyo, Japan
Division name
Department of Neurosurgery
Zip code
143-8541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo 143-8541, Japan
TEL
03-3762-4151
chie.matsuura@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Chie |
| Middle name | |
| Last name | Nakada |
Organization
Toho University Omori Medical Center, Tokyo, Japan
Division name
Department of Neurosurgery
Zip code
143-8541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo 143-8541, Japan
TEL
03-3762-4151
Homepage URL
chie.matsuura@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
None
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
Toho University Omori Hospital Ethics Committee
Address
Toho University Omori Medical Center, 6-11-1 Omorinishi, Ota-ku, Tokyo 143-8541, Japan
Tel
03-5763-6534
omori.rinri@ext.toho-u.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
| 2023 | Year | 02 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
84
Results
The DTI parameter of CST and rCBF correlated with the presence of preoperative motor dysfunction. They also correlated with postoperative motor outcomes.
Results date posted
| 2023 | Year | 02 | Month | 14 | Day |
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was conducted as a retrospective case-control study after obtaining approval from the Ethics Committee of Toho University Omori Hospital. 84 patients with supratentorial brain tumors who underwent surgical treatment at Toho University Medical Center Omori Hospital between January 2016 and June 2022, of whom DTI and SPECT were taken before surgery, were included. We analyzed the data extracted from the medical records and managed the information in the medical records (medical history, findings of paralysis before and after surgery, and imaging findings) in a way that personal information was not revealed.
Management information
Registered date
| 2023 | Year | 02 | Month | 14 | Day |
Last modified on
| 2023 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057315
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
