UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032986 |
|---|---|
| Receipt number | R000036885 |
| Scientific Title | A Pilot Study of Indocyanine Green based Fluorescence Imaging in Locally Advanced Rectal Cancer and Metastatic Lateral Lymph Nodes |
| Date of disclosure of the study information | 2018/06/15 |
| Last modified on | 2018/06/14 11:32:55 |
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Basic information
Public title
A Pilot Study of Indocyanine Green based Fluorescence Imaging in Locally Advanced Rectal Cancer and Metastatic Lateral Lymph Nodes
Acronym
ICG-Based Fluorescence Imaging for Detection of Metastatic Lateral Lymph Nodes of Rectal Cancer
Scientific Title
A Pilot Study of Indocyanine Green based Fluorescence Imaging in Locally Advanced Rectal Cancer and Metastatic Lateral Lymph Nodes
Scientific Title:Acronym
ICG-Based Fluorescence Imaging for Detection of Metastatic Lateral Lymph Nodes of Rectal Cancer
Region
| Japan |
Condition
Condition
Rectal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the possibility to detect sentinel lateral lymph node(s) after Indocyanine Green injections around the tumor in patients with locally advanced rectal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification rate of the sentinel lateral lymph node(s) by using ICG injections around the tumor in patients with locally advanced rectal cancer.
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 |
Interventions/Control_1
Indocyanine Green injections around the tumor
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
Patients with histo-pathological diagnosis of rectal cancer.
Lower edge of the tumor is located below perineal reflection.
Preoperative examinations show curability by surgical resection.
Signature information form and consent by the patient.
Key exclusion criteria
Enlarged or bulky lateral lymph node diameter over 1cm by preoperative imaging
Distant metastasis by preoperative imaging
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Ishii |
Organization
Shinko Hospital
Division name
gastroenterological surgery division
Zip code
Address
1-4-47 Wakinohama Chuo-ku Kobe
TEL
078-261-6711
m.ishii0104@shinkohp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Ishii |
Organization
Shinko Hospital
Division name
gastroenterological surgery division
Zip code
Address
1-4-47 Wakinohama Chuo-ku Kobe
TEL
078-261-6711
Homepage URL
m.ishii0104@shinkohp.or.jp
Sponsor or person
Institute
Shinko Hospital
Institute
Department
Personal name
Funding Source
Organization
Shinko Hospital
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
| 2018 | Year | 06 | Month | 15 | 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 | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 22 | 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
| 2018 | Year | 06 | Month | 14 | Day |
Last modified on
| 2018 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036885
