UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028113 |
|---|---|
| Receipt number | R000032182 |
| Scientific Title | Usefulness of TSPO-PET and related biomarkers in the patients with neuropathic pain |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2019/04/25 12:17:24 |
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Basic information
Public title
Usefulness of TSPO-PET and related biomarkers in the patients with neuropathic pain
Acronym
Usefulness of TSPO-PET in neuropathic pain
Scientific Title
Usefulness of TSPO-PET and related biomarkers in the patients with neuropathic pain
Scientific Title:Acronym
Usefulness of TSPO-PET in neuropathic pain
Region
| Japan |
Condition
Condition
Neuropathic pain
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of the present study is to confirm usefulness of spinal TSPO-PET imaging in the patients with neuropathic pain compared to the normal volunteers. We also investigate the relationship between TSPO-PET finding and blood markers related to the neuroinflammation. The study is going to perform with small population of the patients to obtain the POC of TSPO-PET usefulness for drug development.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Spinal accumulations of TSPO-PET (C-11 DPA-713 PET) in the patients with neuropathic pain, which are evaluated within 4 weeks after entry.
Relationships between spinal accumulation of TSPO-PET and plasma 24OHC or plasma BDNF.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Comparison of spinal TSPO-PET accumulation between the patients with neuropathic pain and normal volunteers. Comparison between spinal TSPO-PET accumulation and plasma 24OHC or plasma BDNF among 2 groups.
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
| 84 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients aged from 20 to 84 years-old (n=15). Normal volunteers aged from 20 to 40 years-old (n=5).
2. Patients with the symptom of definite neuropathic pain or probable neuropathic pain who are diagnosed by the algorithm of the International Association for the Study of Pain.
3. Patients who can provide written informed consent prior to their participation.
Key exclusion criteria
<Exclusion criteria for patients>
1. Pregnant women, nursing mothers and the women who may be pregnant.
2. The patients with the severe psycho-neurologic disease (major depression or schizophrenia).
3. Patients with a history of the severe injury with sliding symptoms due to a vertebral fracture and the backbone trauma within six months.
4. Patients with the discectomy, nerve cauterization, and vertebra plasty within six months.
5. Algetic patients due to articular rheumatism, ankylosing spondylitis, and spinal inflammation or tumor.
6. Patients who are unsolved accident compensation about the pain and financial mediation/suit.
7. Patients with a history of HIV.
8. Patients who are participating into other clinical trials.
9. Patients who are judged to be inadequate as subjects by the principal investigator.
<Exclusion criteria for normal volunteers>
1. Pregnant women, nursing mothers and the women who may be pregnant.
2. Subjects with the severe psycho-neurologic disease (major depression or schizophrenia).
3. Subjects who suffer from hypertention, hyperlipidemia, vascular disease, and/or cardiac disease.
4. The subjects who have symptoms of pain.
5. Subjects who have claustrophobia.
6. Subjects who suffer from malignant tumors.
7. Subjects who have allergy.
8. Subjects who have smoking behavior and alcohol indulgence.
9. Subjects with a history of HIV.
10. Subjects who are participating into other clinical trials.
11. Subjects who are judged to be inadequate as subjects by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Eku |
| Middle name | |
| Last name | Shimosegawa |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Molecular Imaging in Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, 565-0871, JAPAN
TEL
06-6879-3461
eku@mi.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Eku |
| Middle name | |
| Last name | Shimosegawa |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Molecular Imaging in Medicine
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, 565-0871, JAPAN
TEL
06-6879-3461
Homepage URL
eku@mi.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
Funding Source
Organization
SHIONOGI & CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
SHIONOGI & CO., LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Osaka University Hospital
Address
2-2 Yamadaoka, Suita, JAPAN
Tel
06-6210-8289
rinri@hp-crc.med.osaka-u.ac.jp
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 | 10 | 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
11
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
| 2017 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 03 | Month | 15 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 06 | Day |
Last modified on
| 2019 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032182
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/07/06 | TSPO-PET_試験実施計画書_第1.2版_20180427.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
