UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051404 |
|---|---|
| Receipt number | R000058626 |
| Scientific Title | Clinical study of real-time navigation by Curve navigation system in pediatric thoracoabdominal solid tumor resection |
| Date of disclosure of the study information | 2023/06/23 |
| Last modified on | 2023/06/20 15:40:33 |
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Basic information
Public title
Clinical study of real-time navigation by Curve navigation system in pediatric thoracoabdominal solid tumor resection
Acronym
Clinical study of RT navigation by Curve navigation system in pediatric thoracoabdominal solid tumor resection
Scientific Title
Clinical study of real-time navigation by Curve navigation system in pediatric thoracoabdominal solid tumor resection
Scientific Title:Acronym
Clinical study of RT navigation by Curve navigation system in pediatric thoracoabdominal solid tumor resection
Region
| Japan |
Condition
Condition
pediatric thoracoabdominal solid tumor
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will verify whether real-time navigation by the Curve navigation system (Brainlab) contributes to the appropriate setting of the tumor resection line and the improvement of safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete resection of tumor
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Tumor resection is performed while confirming the positional relationship between the tumor and surrounding organs by referring to 3D images constructed from CT and MRI images.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pediatric thoracoabdominal solid tumor
Key exclusion criteria
Organs with large respiratory fluctuations such as lungs and gastrointestinal tract
Tumors that are difficult to visualize with CT or MRI
Patients with contraindications for MRI
Patients for whom intraoperative MRI is difficult
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Tanaka |
Organization
Fukushima medical university hospital
Division name
Pediatric surgery
Zip code
960-1295
Address
1 Hikarigaoka, Fukusima-shi, Fukushima
TEL
024-547-1255
tanaka-h@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Shimizu |
Organization
Fukushima medical university
Division name
Pediatric surgery
Zip code
960-1295
Address
1 Hikarigaoka, Fukusima-shi, Fukushima
TEL
024-547-1255
Homepage URL
shimizu5131@yahoo.co.jp
Sponsor or person
Institute
Fukushima medical 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
Fukushima Medical University, Research Ethics Committee
Address
1 Hikarigaoka, Fukusima-shi, Fukushima
Tel
024-547-1825
fmurec@fmu.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 | 06 | Month | 23 | 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
2
Results
Real-time navigation enabled us to grasp the position and shape of the tumor (1 kidney, 1 liver).
Results date posted
| 2023 | Year | 06 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
congenital mesoblastic nephroma　1
hepatoblastoma 1
Participant flow
Informed consent was obtained from patients with solid tumors for whom this treatment was indicated.
Adverse events
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 17 | 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
| 2023 | Year | 06 | Month | 21 | Day |
Last modified on
| 2023 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058626
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| Registered date | File name |
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| Registered date | File name |
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