UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation on the detection of gastrointestinal tumors after oral administration of aminolevulinic acid-a pilot study
Title of the study (Brief title)	Evaluation on the detection of gastrointestinal tumors after oral administration of ALA
Region	Japan

Condition
Condition	Gastrointestinal tumors
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate on the detection of gastrointestinal tumors after oral administration of aminolevulinic acid.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection and visibility of gastrointestinal tumors after oral administration of ALA
Key secondary outcomes

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 Device,equipment
Interventions/Control_1	ALA (10-20mg/kg) is administered orally 3-4 hours before endoscopy. Using a fluorescence detection system with violet laser diode (VLD-EX)
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1) =>20 years old, <=85 years old. 2) Treatment is scheduled for the lesion. Without distinction the size. 3) Adapted estimated depth for endoscopic treatment case. 4) Endoscopic treatments are including EMR, hybrid EMR, ESD, EMRC, etc. Excluding ablation. 5) Within 60 days of study initiation. WBC => 3,500/mm3 Hb => 8.5 g/dl Plt => 100,000/mm3 T-bil <= 1.5 mg/dl AST (GOT) <= 100 IU/l ALT (GPT) <= 100 IU/l Cr <= 1.2mg/dl 7) Written informed consent.
Key exclusion criteria	1) Patients who can not intake oral medicine. 2) A history of photosensitivity. 3) Porphyria. 4) With malignant hypertension and severe congestive heart failure. Past history of myocardial infraction within the last three months. 5) Poor control of diabetes mellitus. 6) With severe pulmonary fibrosis and acute interstitial pneumonia. 7) Poor control of infection. 8) Patient taking anticoagulants and antiplatelet agents. 9) Patient receiving ferrotherapy. 10) Participating in the study of other division. 11) Patient who is difficult to understand the informed consent. 12) Woman during pregnancy or breast-feeding. 13) Patient is judged to be inappropriate for study participation for any reason by the investigator.
Target sample size	160

Research contact person
Name of lead principal investigator	Yutaka Saito
Organization	National Cancer Center Hospital
Division name	Endoscopy division
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL	03-3542-2511
Email	ytsaito@ncc.go.jp

Public contact
Name of contact person	Eriko So
Organization	National Cancer Center Hospital
Division name	Endoscopy division
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL	03-3542-2511
Homepage URL
Email	esou@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital
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	National Cancer Center Research and Development Fund
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	The Jikei University School of Medicine
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	国立がん研究センター中央病院（東京都）

Other administrative information
Date of disclosure of the study information	2012 Year 12 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 11 Month 27 Day
Anticipated trial start date	2012 Year 12 Month 17 Day
Last follow-up date	2015 Year 04 Month 30 Day
Date of closure to data entry	2015 Year 04 Month 30 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0041-110432
Results	Twenty-three patients with a total of 27 known colorectal lesions were enrolled in the study. Eleven of the lesions were flat or depressed lesions and 16 were sessile. Red fluorescence was observed in 22 out of 27 lesions. Red fluorescence was negative in 4 out of 11 flat or depressed lesions.In comparison with histopathologic findings, the rates of red fluorescence visibility were 62.5？% in low-grade intraepithelial neoplasia, 77.8？% in high-grade neoplasia, and 100？% in submucosal carcinoma. Red fluorescence visibility increased with the degree of dysplasia. There were no significant adverse events identified in this study.
Other related information

Management information
Registered date	2012 Year 12 Month 17 Day
Last modified on	2016 Year 07 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011225