UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective study of liver reserve capacity evaluation using GSA SPECT and MRI in patients with liver tumor who treated by carbon ion radiotherapy
Acronym	Retrospective study of liver reserve capacity evaluation using GSA SPECT and MRI in patients with liver tumor who treated by carbon ion radiotherapy
Scientific Title	Retrospective study of liver reserve capacity evaluation using GSA SPECT and MRI in patients with liver tumor who treated by carbon ion radiotherapy
Scientific Title:Acronym	Retrospective study of liver reserve capacity evaluation using GSA SPECT and MRI in patients with liver tumor who treated by carbon ion radiotherapy
Region	Japan

Condition
Condition	Liver tumor
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the method using GSA SPECT and MRI before and after carbon ion radiotherapy in patients with liver tumor 1. Liver reserve capacity evaluation 2. Early treatment response and prognosis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Assessment of diagnostic abilities of GSA SPECT or MRI in terms of prediction of residual liver reserve capacity before and 3, 12 months after carbon ion radiotherapy
Key secondary outcomes	Correlation among overall survival rate, treatment completion rate in intent to treat group, liver function indices such as Child-Pugh classification, and other clinical data

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients underwent GSA SPECT and MRI, among who were / will be treated with carbon ion radiotherapy for liver tumors from December 2018 to September 2020 at QST hospital.
Key exclusion criteria	1.Other cause of death within 12 months after carbon ion radiotherapy. 2.Recurrence cases within 12 months after carbon ion therapy. 3.Patients who were received other anticancer treatments within 4 months after carbon ion radiotherapy. 4.Patients who refuse to participate in this study.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Ryuichi Middle name Last name Nishii
Organization	National Institute of Radiological Sciences (NIRS), QST
Division name	Dept. of Molecular Imaging and Theranostics
Zip code	263-8555
Address	4-9-1 Anagawa, Inage-ku, Chiba
TEL	043-206-4074
Email	nishii.ryuichi@qst.go.jp

Public contact
Name of contact person	1st name Kana Middle name Last name Yamazaki
Organization	National Institute of Radiological Sciences (NIRS), QST
Division name	Dept. of Molecular Imaging and Theranostics
Zip code	263-8555
Address	4-9-1 Anagawa, Inage-ku, Chiba
TEL	043-206-4076
Homepage URL
Email	yamazaki.kana@qst.go.jp

Sponsor
Institute	National Institute of Radiological Sciences (NIRS), QST
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Certified Review Board, QST
Address	4-9-1 Anagawa, Inage-ku
Tel	043-206-4706
Email	helsinki@qst.go.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	2019 Year 10 Month 30 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	110
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	Completed
Date of protocol fixation	2019 Year 10 Month 16 Day
Date of IRB	2019 Year 10 Month 16 Day
Anticipated trial start date	2019 Year 10 Month 18 Day
Last follow-up date	2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observational study

Management information
Registered date	2019 Year 10 Month 18 Day
Last modified on	2021 Year 10 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043545