UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013791 |
|---|---|
| Receipt number | R000016097 |
| Scientific Title | Feasibility study of in vivo photodynamic diagnosis using 5ALA for head and neck or gastrointestinal cancer |
| Date of disclosure of the study information | 2014/05/12 |
| Last modified on | 2016/04/25 08:44:59 |
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Basic information
Public title
Feasibility study of in vivo photodynamic diagnosis using 5ALA for head and neck or gastrointestinal cancer
Acronym
5ALAPDD invivo
Scientific Title
Feasibility study of in vivo photodynamic diagnosis using 5ALA for head and neck or gastrointestinal cancer
Scientific Title:Acronym
5ALAPDD invivo
Region
| Japan |
Condition
Condition
Head and neck or Gastrointestinal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of in vivo photodynamic diagnosis using 5ALA for head and neck or gastrointestinal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Concordance rate between Fluorescence intensity and pathological results
Key secondary outcomes
Adverse event and
PpIX level in biopsy specimensand plasma
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
To perform photodynamic diagnosis 4-6 hours later after oral administration of 5ALA
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)Tis-T1, oropharynx or hypopharynx cancer, esophageal cancer, gastric cancer, colon cancer.
2)=> 20 years old
3)Performance status (ECOG) 0 or 1
4)Adequate organ function
5)Written informed consent
Key exclusion criteria
1)Photosensitivity
2)Porphyria
3)pregnant or nursing women
4)Liver cirrhosis, acute or chronic hepatitis
5)Active bacterial or fungal infection requiring systemic medication
6)Positive HBs antigen, HCV antibody or known positive serology for HIV
7)Patient is judged to be inappropriate for study enrollment by investigator
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomonori Yano |
Organization
National Cancer Center Hospital East
Division name
Endoscopy Division
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
04-7133-1111
toyano@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Sato |
Organization
National Cancer Center Exploratory Oncology Research &Clinical Trial Center
Division name
Clinical trial section
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
04-7133-1111
Homepage URL
ctu_dc@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Health and Labor Sciences Research Grant
SBI Pharmaceuticals Co., Ltd.
FUJIFILM Corporation
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
drug supply : SBI Pharmaceuticals Co., Ltd.
device supply : FUJIFILM Corporation
Tokyo Institute of Technology
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
| 2014 | Year | 05 | Month | 12 | 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
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 19 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 23 | Day |
Last modified on
| 2016 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016097
