UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024989 |
|---|---|
| Receipt number | R000028755 |
| Scientific Title | Exploratory clinical study on Indocyanine Green (ICG) navigated lymph node dissection in robot-assisted radical prostatectomy |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2018/05/28 10:44:07 |
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Basic information
Public title
Exploratory clinical study on Indocyanine Green (ICG) navigated lymph node dissection in robot-assisted radical prostatectomy
Acronym
RARP-ICG study
Scientific Title
Exploratory clinical study on Indocyanine Green (ICG) navigated lymph node dissection in robot-assisted radical prostatectomy
Scientific Title:Acronym
RARP-ICG study
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will explore the possibility of individualized pelvic lymph node dissection according to individual differences in robot-assisted radical prostatectomy surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lymph flow evaluatable ratio, lymph flow pattern classifiable ratio, lymph flow pattern classifiable ratio by lesion site, classification lymph flow pattern intra-lymph node metastasis rate
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
After injecting ICG into the prostate gland, observe with a near infrared (NIR) camera and classify lymph flow. The ICG positive site within the template dissection area is dissected and additionally dissected out of the ICG positive site outside the template dissection supernatant is performed.
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
| 75 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Diagnosed as prostate cancer pathologically by prostate biopsy
2) Diagnosed as localized prostate cancer (T1-2N0M0) or locally advanced cancer (T3aN0M0) by DRE, CT, MRI
3) 20 years old and over, under 75
4) ECOG performance status score: 0 and 1
5) With or without measurable lesions
6) Provision of pretreatment: No history of hormone therapy, no history of surgery in the pelvis, no history of operation of the prostate
7) No restrictions on concomitant medications and combination therapy
8) With regard to complications, there is no restriction as long as it is judged that robot-assisted prostatectomy and extended lymph node dissection is possible by the attending physician
9) About patient participation The patient got consent in writing from the patient himself
Key exclusion criteria
Exclude those with allergic history in ICG
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Fujimoto |
Organization
National Cancer Center Hospital:Tsukiji Campus
Division name
Urology division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
hfujimot@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiko Hara |
Organization
National Cancer Center Hospital:Tsukiji Campus
Division name
Urology division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, Japan
TEL
03-3542-2511
Homepage URL
thara@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital:Tsukiji Campus
Institute
Department
Personal name
Funding Source
Organization
Urology division
National Cancer Center Hospital:Tsukiji Campus
Organization
Division
Category of Funding Organization
Government offices of other countries
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
| 2017 | Year | 02 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 25 | Day |
Last modified on
| 2018 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028755
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