UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016180 |
|---|---|
| Receipt number | R000017224 |
| Scientific Title | In vivo fluorescence detection of gastrointestinal cancer by photodynamic diagnosis |
| Date of disclosure of the study information | 2015/01/11 |
| Last modified on | 2015/01/11 22:20:49 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
In vivo fluorescence detection of gastrointestinal cancer by photodynamic diagnosis
Acronym
Virtual photodynamic diagnosis for the gastrointestinal cancer
Scientific Title
In vivo fluorescence detection of gastrointestinal cancer by photodynamic diagnosis
Scientific Title:Acronym
Virtual photodynamic diagnosis for the gastrointestinal cancer
Region
| Japan |
Condition
Condition
gastrointestinal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Photodynamic diagnosis (PDD) is an imaging technology that is based on the fundamental biological features of cancer cells. Five-aminolevulinic acid (ALA), a precursor of photosensitizing protoporphyrin IX (PpIX) has been applied. This study was aimed to investigate the feasibility of ALA-mediated PDD for detecting gastrointestinal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
detection and demarcation of GI tumors and non-tumor tissue
Key secondary outcomes
Base
Study type
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-mediated fluorescent decection by endoscopy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with GI cancers or the highly suspected ones
Key exclusion criteria
porphyria
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Nakao |
Organization
Nagasaki University Hospital
Division name
Gastroenterology and Hepatology
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7200
kazuhiko@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hajime Isomoto |
Organization
Nagasaki University Hospital
Division name
Gastroenterology and Hepatology
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7200
Homepage URL
hajimei2002@yahoo.co.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Gastric cancer and Barett' cancer 23 lesions from 20 patients were enrolled. Nigntenn lesions were positive. Differentiated and elevated lesions tendded to be higher positivity for PDD.
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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 08 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 11 | Day |
Last modified on
| 2015 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017224
