UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034573
Receipt number R000039413
Scientific Title Effect of radiation according to diagnostic nuclear medicine on DNA
Date of disclosure of the study information 2018/10/19
Last modified on 2023/10/24 15:49:19

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Basic information

Public title

Effect of radiation according to diagnostic nuclear medicine on DNA

Acronym

Effect of diagnostic nuclear medicine on DNA

Scientific Title

Effect of radiation according to diagnostic nuclear medicine on DNA

Scientific Title:Acronym

Effect of diagnostic nuclear medicine on DNA

Region

Japan


Condition

Condition

All the diseases which FDG PET imaging are approved.

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To detect and quantify the DNA damage according to diagnostic nuclear medicine procedures with gamma-H2AX and chromosomal analysis using FISH method. Equality of detection power of DNA damage using gamma-H2AX measuring and chromosomal analysis is also assessed.

Basic objectives2

Others

Basic objectives -Others

Radiation effect

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Changes of DNA damage between before FDG injection, before FDG PET image aquisition and after aquisition.

Key secondary outcomes

correlation between DNA damage and blood sample data/history/FDG dose/FDG PET acquisition parameters.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

Who are perfomed FDG PET/CT due to the diseases which are approved for FDG PET imagings.

Key exclusion criteria

Patients with histroy of FDG PET examination with in one year.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Takashi
Middle name
Last name Kudo

Organization

Nagasaki University

Division name

Department of Radioisotope Medicine, Atomic Bomb Disease Institute

Zip code

8528523

Address

12-4 Sakamoto-1-chome, Nagasaki, Nagasaki

TEL

095-819-7101

Email

tkudo123@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name TAKASHI
Middle name
Last name KUDO

Organization

Nagasaki University

Division name

Department of Radioisotope Medicine, Atomic Bomb Disease Institute

Zip code

8528523

Address

12-4 Sakamoto-1-chome, Nagasaki, Nagasaki

TEL

095-819-7101

Homepage URL


Email

tkudo123@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki University

Institute

Department

Personal name



Funding Source

Organization

Nagasaki 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

Nagasaki University Hospital

Address

7-1 Sakamoto-1chome, Nagasaki

Tel

095-819-7200

Email

gaibushikin@ml.nagasaki-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

2018 Year 10 Month 19 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

71

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

2018 Year 10 Month 15 Day

Date of IRB

2018 Year 09 Month 23 Day

Anticipated trial start date

2018 Year 10 Month 22 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We will acquire DNA damage measurement. Data are not yet achieved.


Management information

Registered date

2018 Year 10 Month 19 Day

Last modified on

2023 Year 10 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039413


Research Plan
Registered date File name
2022/04/26 2021_Diag_rad_DNA_RC1.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name