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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024519
Receipt No. R000027602
Scientific Title A study of differential diagnosis of atypical renal tumors by quantitative Tc-99m MIBI SPECT/CT and FDG-PET/CT
Date of disclosure of the study information 2016/10/31
Last modified on 2019/04/01

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Basic information
Public title A study of differential diagnosis of atypical renal tumors by quantitative Tc-99m MIBI SPECT/CT and FDG-PET/CT
Acronym A study of differential diagnosis of atypical renal tumors by quantitative Tc-99m MIBI SPECT/CT
Scientific Title A study of differential diagnosis of atypical renal tumors by quantitative Tc-99m MIBI SPECT/CT and FDG-PET/CT
Scientific Title:Acronym A study of differential diagnosis of atypical renal tumors by quantitative Tc-99m MIBI SPECT/CT
Region
Japan

Condition
Condition Renal tumors presenting atypical finding on routine CT and/or MRI, considering surgical removal
Classification by specialty
Urology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 A aim of this study is to investigate the ability of a combination of SUVs by quantitative Tc-99m MIBI SPECT/CT and FDG PET/CT for the differential diagnosis of atypical renal tumors with difficulty of diagnosis before surgical removal
Basic objectives2 Others
Basic objectives -Others Development of a differential diagnosis method of renal tumors using Tc-99m-MIBI SPECT/CT and FDG-PET/CT
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Correlation between MIBI SUV and pathological diagnosis of atypical renal tumor (renal oncocytoma or renal cell carcinoma)
Key secondary outcomes Correlation between FDG SUV and pathological diagnosis of atypical renal tumor

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 Diagnosis
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Tc-99m-MIBI SPECT/CT SUV measurment
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

Not applicable
Gender Male and Female
Key inclusion criteria ・ A patient with renal tumor more than 2cm in maximum diameter presenting atypical finding on conventional CT and/or MRI, indicating surgical removal
・ A patient more than 20 years-old at consent to the study
・ A patient who consents to this study on the document form
Key exclusion criteria ・ A patient with typical renal cell cancer presenting findings such as early-phase enhancement on contrast-enhancement CT
・ A patient with renal tumor difficult to be removed surgically
・ A patient with bad general condition who is not appropriate for any surgery and/or test
・ A patient suspected pregnant
・ A patient who deny the prosecution of this study in the middle of the study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Ichiei
Middle name
Last name Kuji
Organization Saitama Medical University International Medical Center
Division name Department of Nuclear Medicine
Zip code 350-1298
Address Yamane 1397-1, Hidaka, Saitama
TEL 042-984-4147
Email kuji@saitama-med.ac.jp

Public contact
Name of contact person
1st name Ichiei
Middle name
Last name Kuji
Organization Saitama Medical University International Medical Center
Division name Clinical Trial Support Center
Zip code 350-1298
Address Yamane 1397-1, Hidaka, Saitama
TEL 042-984-4147
Homepage URL
Email chikens@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Saitama Medical University International Medical Center Crinical trial IRB
Address 1397-1 Yamane, Hidaka-shi, Saitama 350-1298
Tel 042-984-4523
Email chikens@saitama-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
2016 Year 10 Month 31 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 4
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 Terminated
Date of protocol fixation
2016 Year 10 Month 15 Day
Date of IRB
2016 Year 11 Month 09 Day
Anticipated trial start date
2016 Year 11 Month 24 Day
Last follow-up date
2019 Year 01 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Body weight, Bone pain (VAS score), Blood (blood counts, PSA, ALP, PSA, BAP, 1-CTP) Urine (NTX),Bone scintigraphy (E.O.D.,BSI,SUV)

Management information
Registered date
2016 Year 10 Month 21 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027602

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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