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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013791
Receipt No. 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

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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
Email 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
Email ctu_dc@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016097

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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