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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028113
Receipt No. 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

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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
Email 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
Email eku@mi.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.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


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