UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009336 |
|---|---|
| Receipt number | R000010888 |
| Scientific Title | Assessing the efficacy of FDG-PET(18F-fluorodeoxy glucose positron emission tomography) in the early detection of RCC (Renal cell carcinoma) in patients with ESRD(End stage renal disease) |
| Date of disclosure of the study information | 2012/11/19 |
| Last modified on | 2017/05/25 21:11:48 |
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Basic information
Public title
Assessing the efficacy of FDG-PET(18F-fluorodeoxy glucose positron emission tomography) in the early detection of RCC (Renal cell carcinoma)
in patients with ESRD(End stage renal disease)
Acronym
FDG-PET in RCC related with ESRD
Scientific Title
Assessing the efficacy of FDG-PET(18F-fluorodeoxy glucose positron emission tomography) in the early detection of RCC (Renal cell carcinoma)
in patients with ESRD(End stage renal disease)
Scientific Title:Acronym
FDG-PET in RCC related with ESRD
Region
| Japan |
Condition
Condition
Renal cell carcinoma related with end stage renal disease
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Renal Cell Carcinoma (RCC) is prevalent in patients with Acquired Cystic Disease of Kidney (ACDK) due to the End Stage Renal Disease (ESRD). It is reported that 4.2% of RCC was found on kidneys with ESRD which was removed at the time of transplantation.
Autosomal Dominant Polycystic Kidney Disease (ADPKD), a hereditary disease which occurs in one of 1,000 patients, commonly progressed into renal failure and accounts for 3-5% of hemodialysis patients. The incidence of RCC in ESRD related to this disease is reported to be 12% which is higher compared with the incidence of RCC in ESRD from other renal disease.
Due to FDG excretion from the urinary system, FDG-PET is generally considered inappropriate for urinary tract tumor detection. However, the absence of kidney physiological accumulation of FDG in hemodialysis patient due to ESRD, making the accurate visualization of urinary tract tumor is possible.
The aim of this study is to evaluate the diagnostic performance of FDG-PET in RCC detection of ESRD patients and to further evaluate its potential for RCC screening.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of abnormal uptake of FDG in kidney which would suggest the presence of malignancy.
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
Diagnosis
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
one injection of 18F-fluorodeoxy glucose,
5MBq/Kg
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
End stage renal disease patient under hemodialysis
Key exclusion criteria
patients with lactation,pregnancy and suspected pregnancy
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromi Hirasawa |
Organization
Gunma University Hospital
Division name
department of nuclear medecine
Zip code
Address
3-39-15 showa-machi maebashi gunnma
TEL
027-220-8612
h.hirasawa@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromi Hirasawa |
Organization
Gunma University Hospital
Division name
department of nuclear medecine
Zip code
Address
3-39-15 showa-machi maebashi gunnma
TEL
027-220-8407
Homepage URL
h.hirasawa@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
department of nuclear medecine
Institute
Department
Personal name
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
Address
Tel
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
| 2012 | Year | 11 | Month | 19 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 15 | Day |
Last modified on
| 2017 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010888
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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