UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019448 |
|---|---|
| Receipt number | R000022431 |
| Scientific Title | Feasibility study of fluorescence-guided surgery using 5-aminolevulinic acid in head and neck cancer. |
| Date of disclosure of the study information | 2015/10/22 |
| Last modified on | 2019/05/06 15:01:59 |
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Basic information
Public title
Feasibility study of fluorescence-guided surgery using 5-aminolevulinic acid in head and neck cancer.
Acronym
Feasibility study of fluorescence-guided surgery using 5-ALA in head and neck cancer.
Scientific Title
Feasibility study of fluorescence-guided surgery using 5-aminolevulinic acid in head and neck cancer.
Scientific Title:Acronym
Feasibility study of fluorescence-guided surgery using 5-ALA in head and neck cancer.
Region
| Japan |
Condition
Condition
Head and neck cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of intraoperative fluorescence imaging of head and neck cancer after the administration of 5-ALA.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The comparison of fluorescence emission and histological lesion in resected specimens
Key secondary outcomes
Complications
Recurrence 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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Preoperative oral administration of 5-ALA (20 mg/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
Patients of head and neck cancer with surgical indication
Key exclusion criteria
Patients with porphyria, pregnancy, severe cardiac, renal or hepatic disorders or poor general condition
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Miyamoto |
Organization
Kitasato University School of Medicine
Division name
Department of Otorhinolaryngology-Head and Neck Surgery
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8111
s-miya@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Miyamoto |
Organization
Kitasato University School of Medicine
Division name
Department of Otorhinolaryngology-Head and Neck Surgery
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8111
Homepage URL
s-miya@kitasato-u.ac.jp
Sponsor or person
Institute
Department of Otorhinolaryngology-Head and Neck Surgery, Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University Medical Ethics Organization
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel
042-778-8111
rinrib@med.kitasato-u.ac.jp
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
北里大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 22 | Day |
Related information
URL releasing protocol
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-15K10824/
Publication of results
Unpublished
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-15K10824/
Number of participants that the trial has enrolled
3
Results
Fluorescence imaging using ALA did not detect significant signal in head and neck cancer. Because tumor differentiation presumably affected the unfavorable results, the case with poor differentiated squamous cell carcinoma (SCC) came to prospective objective. However, there was no candidate meeting conditions.
Thus, the fluorescence imaging using ALA might be unpractical at least in the case with differentiated SCC which fills majority of head and neck cancer.
Results date posted
| 2019 | Year | 05 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
hypopharyngeal cancer and 2 cases with tongue cancer
Participant flow
All three cases were discharged with no additional duration of hospitalization after fluorescence-guided surgery.
Adverse events
None
Outcome measures
The intensity of fluorescence and the contributory effect to excision accuracy were imponderable due to no significant fluorescent signal in the imaging.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 22 | Day |
Last modified on
| 2019 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022431
