UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective study to assess diagnostic ability of IMP SPECT imaging and its fusion images with CT or MRI in patients with choroidal tumors in terms of the prediction of early treatment response after carbon ion radiotherapy
Acronym	Retrospective study to assess diagnostic ability of IMP SPECT imaging and its fusion images with CT or MRI in patients with choroidal tumors
Scientific Title	Retrospective study to assess diagnostic ability of IMP SPECT imaging and its fusion images with CT or MRI in patients with choroidal tumors in terms of the prediction of early treatment response after carbon ion radiotherapy
Scientific Title:Acronym	Retrospective study to assess diagnostic ability of IMP SPECT imaging and its fusion images with CT or MRI in patients with choroidal tumors
Region	Japan

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

Objectives
Narrative objectives1	To assess IMP SPECT imaging for accurate diagnosis before and after carbon ion radiotherapy in patients with choroidal tumors. 1) Usefulness of IMP SPECT imaging and its fusion images with CT or MRI. 2) Usefulness of IMP SPECT semi-quantitative evaluation method.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Usefulness of IMP-SPECT imaging and its fusion images with CT or MRI, and IMP SPECT semi-quantitative evaluation method. 1) diagnostic ability of choroidal tumor, 2) local control rate, and 3) disease-free recurrence period.
Key secondary outcomes	Correlation among semi-quantitative evaluation methods such as SUV of IMP SPECT, tumor size, and the presence or absence of distant metastasis.

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 who were performed IMP SPECT and CT or MRI for choroidal tumor treatment, among who were / will be treated with carbon ion radiotherapy for choroidal tumors from November 2017 to March 2021 at QST hospital.
Key exclusion criteria	1. Other cause of death within 12 months after carbon ion radiotherapy. 2. Patients who were received other anticancer treatments within 4 months after carbon ion radiotherapy. 3. 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, Chiba
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 03 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
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 09 Month 20 Day
Date of IRB	2019 Year 09 Month 20 Day
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2022 Year 08 Month 31 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 01 Day
Last modified on	2022 Year 10 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043514