UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007891 |
|---|---|
| Receipt number | R000009297 |
| Scientific Title | Evaluation of navigation surgery in head and neck cancer with ICG near-infrared fluorescence imaging. |
| Date of disclosure of the study information | 2012/05/07 |
| Last modified on | 2013/03/21 22:42:09 |
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Basic information
Public title
Evaluation of navigation surgery in head and neck cancer with ICG near-infrared fluorescence imaging.
Acronym
Evaluation of navigation surgery in head and neck cancer with ICG near-infrared fluorescence imaging.
Scientific Title
Evaluation of navigation surgery in head and neck cancer with ICG near-infrared fluorescence imaging.
Scientific Title:Acronym
Evaluation of navigation surgery in head and neck cancer with ICG near-infrared fluorescence imaging.
Region
| Japan |
Condition
Condition
oral and oropharyngeal cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy of tumor optical imaging by intraoperative ICG near-infrared fluorescence in head and neck cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Specific accumulation of ICG in head and neck tumor.
efficacy of ICG near-infrared fluorescence imaging in tumor resection.
Key secondary outcomes
1.evaluation of surgical margin.
2.minimum invasive surgery and function preservation.
3.survival rate
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
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Iintravenous adminstration of ICG.
Identification of limit of invasion with intraoperative ICG near-infrared fluorescence imaging.
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
1.Patient age 20 years and above
2.The lesion nsked in neck or oral and pharynx
3.Patients who are planned radical surgery for primary site.
4. Patients who were provided written informed consent
Key exclusion criteria
1.Pregnancy or lactating women or women with suspected pregnancy
2.Patients having past history of hypersensitivity to iodine
3.Patient judged by the investigator to be unfit to be enrolled into the study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junkichi Yokoyama |
Organization
Juntendo university school of medicine
Division name
Department of Otolaryngology, head and neck surgery
Zip code
Address
2-1-2, Hongo, Bunkyou-ku, Tokyo
TEL
03-3813-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntendo university school of medicine
Division name
Department of Otolaryngology, head and neck surgery
Zip code
Address
TEL
03-3813-3111
Homepage URL
Sponsor or person
Institute
Juntendo university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Health and Labor Science Reserch Grant for Clinical Cancer Reserch
Organization
Division
Category of Funding Organization
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 | 05 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 05 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | 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 | 05 | Month | 05 | Day |
Last modified on
| 2013 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009297
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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