UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009569 |
|---|---|
| Receipt number | R000011225 |
| Scientific Title | Evaluation on the detection of gastrointestinal tumors after oral administration of aminolevulinic acid-a pilot study |
| Date of disclosure of the study information | 2012/12/17 |
| Last modified on | 2016/07/28 00:17:22 |
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Basic information
Public title
Evaluation on the detection of gastrointestinal tumors after oral administration of aminolevulinic acid-a pilot study
Acronym
Evaluation on the detection of gastrointestinal tumors after oral administration of ALA
Scientific Title
Evaluation on the detection of gastrointestinal tumors after oral administration of aminolevulinic acid-a pilot study
Scientific Title:Acronym
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
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
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
| 1st name | |
| Middle name | |
| Last name | Yutaka Saito |
Organization
National Cancer Center Hospital
Division name
Endoscopy division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
ytsaito@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eriko So |
Organization
National Cancer Center Hospital
Division name
Endoscopy division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
esou@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
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)
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
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0041-110432
Number of participants that the trial has enrolled
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.
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
| 2012 | Year | 11 | Month | 27 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011225
