UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of in vivo photodynamic diagnosis using 5ALA for head and neck or gastrointestinal cancer
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Tomonori Yano
Organization	National Cancer Center Hospital East
Division name	Endoscopy Division
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	Akihiro Sato
Organization	National Cancer Center Exploratory Oncology Research &Clinical Trial Center
Division name	Clinical trial section
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000016097