UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026091 |
|---|---|
| Receipt number | R000029984 |
| Scientific Title | Optimal MRI sequence for evaluation of metabolism of 5-aminolevulinic acid (5-ALA) |
| Date of disclosure of the study information | 2017/02/10 |
| Last modified on | 2018/12/13 09:21:13 |
* 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
Optimal MRI sequence for evaluation of metabolism of 5-aminolevulinic acid (5-ALA)
Acronym
MRI sequence for evaluation of metabolism of 5-ALA
Scientific Title
Optimal MRI sequence for evaluation of metabolism of 5-aminolevulinic acid (5-ALA)
Scientific Title:Acronym
MRI sequence for evaluation of metabolism of 5-ALA
Region
| Japan |
Condition
Condition
malignant tumor
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the optimal MRI sequenece of the metabolism of 5-ALA
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Determination of optimal sequence for detecting the 5-ALA metabolism
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 |
Interventions/Control_1
5-ALA 1Vial 1day
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Obtained informed consent
Equal or more than 20 years old
Key exclusion criteria
Presence of hypersensitivity for Porphyrin
Presence of Porphyria
Taking medicine as follows
Tetracycline antibiotics
Sulfonamide
New quinolone antibacterial agent
Hypericin
Food containing horse millet
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiko Tsuchida |
Organization
Tokyo Medical University
Division name
Gastrointestinal and Pediatric Surgery
Zip code
Address
6-7-1, Nishi-Shinjuku, Shinjuku-ku
TEL
03-3342-6111
akihikot@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Saito |
Organization
Tokyo Medical University
Division name
Radiology
Zip code
Address
6-7-1, Nishi-Shinjuku, Shinjuku-ku
TEL
03-3342-6111
Homepage URL
saito-k@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 02 | Month | 10 | 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
Results
We performed this study in 4 cases, however, taget organ parathyroid could not be detect in MRI. Therfore, we stopped 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
Terminated
Date of protocol fixation
| 2016 | Year | 04 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 08 | 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
| 2017 | Year | 02 | Month | 10 | Day |
Last modified on
| 2018 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029984
