UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030040
Receipt number R000034304
Scientific Title Test-retest reproducibility of PET scan with adenosine A2A receptor ligand [C-11]Preladenant in healthy volunteers.
Date of disclosure of the study information 2017/11/20
Last modified on 2022/11/24 16:53:57

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Basic information

Public title

Test-retest reproducibility of PET scan with adenosine A2A receptor ligand [C-11]Preladenant in healthy volunteers.

Acronym

Reproducibility study of [C-11] Preladenant

Scientific Title

Test-retest reproducibility of PET scan with adenosine A2A receptor ligand [C-11]Preladenant in healthy volunteers.

Scientific Title:Acronym

Reproducibility study of [C-11] Preladenant

Region

Japan


Condition

Condition

Healthy volunteer

Classification by specialty

Neurology Radiology Neurosurgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Test-retest reproducibility study of [C-11]Preladenant. Assessment of stability and variation of the PET measures in healthy volunteers.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Reproducilibity of PET measures between test-retest scans within 12 months interval.

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

Prevention

Type of intervention

Medicine

Interventions/Control_1

The dosage in the vain of [C-11]Preladenant for PET/CT imaging will be performed twice within 12 months interval.

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

60 years-old >=

Gender

Male

Key inclusion criteria

1. The subject who has intention to participate in this study, and signed informed consent.
2. Male subject of >=20 and <60 years old.
The subject who judged by clinical investigator by means of physical examination and laboratory tests to be eligible as a participant in this study.

Key exclusion criteria

1. The subject who has dysfunction in the liver / kidney.
2. The subject who has abnormal findings in the central nervous system.
3. The subject having cardiac failure.
4. The subject with a history of a drug or food allergy.
5. Smokers
The subject who juddged by the clinical investigator to be inappropriate as a participant in this study.

Target sample size

8


Research contact person

Name of lead principal investigator

1st name Kenji
Middle name
Last name Ishii

Organization

Tokoyo Metropolitan Institute of Gerontology

Division name

Research Team for Neuroimaging

Zip code

173-0015

Address

35-2 Sakae-cho, Itabashi-ku, Tokyo 1730015, Japan

TEL

03-3964-3241

Email

ishii@pet.tmig.or.jp


Public contact

Name of contact person

1st name Kenji
Middle name
Last name Ishii

Organization

Tokoyo Metropolitan Institute of Gerontology

Division name

Research Team for Neuroimaging

Zip code

173-0015

Address

35-2 Sakae-cho, Itabashi-ku, Tokyo

TEL

0339643241

Homepage URL


Email

ishii@pet.tmig.or.jp


Sponsor or person

Institute

Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology

Institute

Department

Personal name



Funding Source

Organization

Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Clinical Research Review Board, Tokyo Metropolitan Geriatric Center

Address

Sakaecho 35-2, Itabashi-ku, Tokyo 1730015, Japan

Tel

0339643241

Email

naomi_hasegawa@tmghig.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 11 Month 20 Day


Related information

URL releasing protocol

https://doi.org/10.1007/s12149-021-01678-5

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1007/s12149-021-01678-5

Number of participants that the trial has enrolled

8

Results

Global mean aTRV was 20% for VT and 14% for VT/fP (ICC, 0.72 for VT and 0.87 for VT/fP). Global mean aTRV of DVR was 13% for Logan plot and 10% for LGAR (ICC, 0.70 for Logan plot and 0.81 for LGAR). DVR estimates using LGAR and Logan plot were in good agreement (r2 = 0.96). Despite low serum caffeine levels, significant concentration-dependent effects on [11C]PLN binding to target regions were observed (p<0.01).

Results date posted

2022 Year 11 Month 24 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 09 Month 26 Day

Baseline Characteristics

Eight healthy male volunteers were enrolled (mean age +- SD, 26 +- 10y; range 21-51 y).

Participant flow

Dynamic 90 min PET scans were performed twice at the same time of the day to avoid the effect of diurnal variation. Subjects refrained from caffeine from 12 h prior to scanning, and serum caffeine was measured before radioligand injection. Arterial blood was sampled repeatedly during scanning and the fraction of the parent compound in plasma was determined. Total distribution volume (VT) was estimated using 1- and 2-tissue compartment models (1-TCM and 2-TCM, respectively) and Logan graphical analysis (Logan plot) (t* = 30 min). Plasma-free fraction (fP) of [11C]PLN was measured and used for correlation of VT values. Distribution volume ratio (DVR) was calculated from VT of target and reverence regions and obrtained by noninvasive Logan graphical reverence tissue model (LGAR) (t* = 30 min). Absolute test-retest variability (aTRV), and intra-class correlation coefficient (ICC) of VT and DVR were calculated as indices of repeatability. Correlation between DVR and serum concentration of caffeine (a nonselective A2AR blocker) was analyzed by Pearson's correlation analysis.

Adverse events

No adverse events were observed.

Outcome measures

Absolute test-retest variability (aTRV), and intraclass correlation coefficient (ICC) of VT and DVR.

Plan to share IPD

The datasets generated during and analyzed during the current study are available from the corresponding author on reasonable request.

IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 09 Month 14 Day

Date of IRB

2021 Year 08 Month 30 Day

Anticipated trial start date

2017 Year 11 Month 21 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2019 Year 06 Month 30 Day

Date analysis concluded

2022 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 11 Month 20 Day

Last modified on

2022 Year 11 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034304


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name