UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024519 |
|---|---|
| Receipt number | 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 12:45:37 |
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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
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
chikens@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027602
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