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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009336
Receipt No. 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

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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
Email 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
Email h.hirasawa@gunma-u.ac.jp

Sponsor
Institute Gunma University Hospital
department of nuclear medecine
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
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010888

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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