UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017766
Receipt number R000020574
Scientific Title 18F-NaF PET for the evaluation of bone and calcification
Date of disclosure of the study information 2015/08/01
Last modified on 2020/04/11 09:42:07

* 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

18F-NaF PET for the evaluation of bone and calcification

Acronym

18F-NaF PET

Scientific Title

18F-NaF PET for the evaluation of bone and calcification

Scientific Title:Acronym

18F-NaF PET

Region

Japan


Condition

Condition

Patients with or suspected bone and soft-tissue tumor and arteriosclerosis

Classification by specialty

Medicine in general Surgery in general Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To improve the diagnostic accuracy for detection of bone and soft-tissue tumor and arteriosclerosis

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Positive predictive value

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

PET or PET/CT imaging will be performed after injection of 18F-NaF. Images will be evaluated for detection of lesion.

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 or suspected bone and soft-tissue tumor and arteriosclerosis

Key exclusion criteria

Those who have not signed the informed consent form

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yoshihiro
Middle name
Last name Nishiyama

Organization

Faculty of Medicine, Kagawa University

Division name

Radiology

Zip code

761-0793

Address

1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan

TEL

087-898-5111

Email

yuka@kms.ac.jp


Public contact

Name of contact person

1st name Takashi
Middle name
Last name Norikane

Organization

Faculty of Medicine, Kagawa University

Division name

Radiology

Zip code

761-0793

Address

1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan

TEL

087-898-5111

Homepage URL


Email

t-nori@kms.ac.jp


Sponsor or person

Institute

Kagawa University

Institute

Department

Personal name



Funding Source

Organization

Kagawa 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

Kagawa University

Address

1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan

Tel

0878985111

Email

yuka@kms.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

香川大学医学部附属病院/Kagawa University Hospital


Other administrative information

Date of disclosure of the study information

2015 Year 08 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


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

2015 Year 08 Month 01 Day

Date of IRB

2015 Year 09 Month 01 Day

Anticipated trial start date

2015 Year 09 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 06 Month 01 Day

Last modified on

2020 Year 04 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020574


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name