UMIN-CTR Clinical Trial

Basic information
Public title	Photodynamic diagnosis (PDD) of Peritoneal disseminations of gastric cancer using intraoperative fluorescence laparoscopy with 5-ALA administration.
Acronym	Photodynamic diagnosis of Peritoneal disseminations of gastric cancer with 5-ALA.
Scientific Title	Photodynamic diagnosis (PDD) of Peritoneal disseminations of gastric cancer using intraoperative fluorescence laparoscopy with 5-ALA administration.
Scientific Title:Acronym	Photodynamic diagnosis of Peritoneal disseminations of gastric cancer with 5-ALA.
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate a photodynamic diagnostic power for peritoneal dissemination of gastric cancer with 5-aminolevulinic acid.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Additive effect to a photodynamic diagnostic power for peritoneal dissemination of gastric cancer with 5-ALA.
Key secondary outcomes	Sensitivity, specificity, positive predictive value, negative predictive value of examination for peritoneal disseminated malignant nodules from primary gastric cancer using photodynamic diagnosis with 5-ALA.

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	5-aminolevulinic acid(5-ALA) is administered orally, 3-4 hours before start of an operation. Under general (and epidural) anesthesia and peumoperitoneum with carbon dioxide gas, laparoscopic examination is performed intraabdominally with blue-light exciting fluorescence and white-light. Observed by white-light only, blue-light only, and both white and blue-light, peritoneal nodules are snapshooted and counted. Some of them are excisional biopsied and confirmed their pathological diagnoses to compare with their photodynamic diagnoses.
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who have advanced gastric cancer with serosal invasion and scheduled a staging laparoscopy or a curative gastric resection. Patients who signed informed consent.
Key exclusion criteria	Porphyria. A history of photosensitivity. Taking drugs that may cause photosensitivity. Patients are judged to be inappropriate to participate in this study for any reason by the investigators.
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Kazuhiro Middle name Last name Imamura
Organization	Tokyo Metropolitan Tama Medical Center
Division name	Department of Surgery
Zip code	183-8524
Address	2-8-29 Musashidai, Fuchu-shi, Tokyo, Japan
TEL	042-323-5111
Email	imamurakazu@mac.com

Public contact
1st name of contact person	1st name Kazuhiro Middle name Last name Imamura
Organization	Tokyo Metropolitan Tama Medical Center
Division name	Department of Surgery
Zip code	183-8524
Address	2-8-29 Musashidai, Fuchu-shi, Tokyo, Japan
TEL	042-323-5111
Homepage URL
Email	imamurakazu@mac.com

Sponsor
Institute	Tokyo Metropolitan Tama Medical Center
Institute
Department

Funding Source
Organization	Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Metropolitan Tama Medical Center
Address	2-8-29 Musashidai, Fuchu-shi, Tokyo, Japan
Tel	0423235111
Email	Kaori_Murase@member.metro.tokyo.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	H280502001
Org. issuing International ID_1	Tokyo Metropolitan Government
Study ID_2
Org. issuing International ID_2
IND to MHLW	102

Institutions
Institutions	東京都立多摩総合医療センター

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 01 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	12
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	2016 Year 01 Month 12 Day
Date of IRB	2016 Year 01 Month 14 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date	2018 Year 08 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	2017 Year 03 Month 30 Day
Last modified on	2019 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030751