UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023327
Receipt number R000026879
Scientific Title The retrospective study of the correlation between I-123 uptakes and iodine concentrations of thyroid glands for patients with hyperthyroidism
Date of disclosure of the study information 2016/08/01
Last modified on 2021/03/25 09:15:42

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Basic information

Public title

The retrospective study of the correlation between I-123 uptakes and iodine concentrations of thyroid glands for patients with hyperthyroidism

Acronym

The retrospective study of the correlation between I-123 uptakes and iodine concentrations of thyroid glands for patients with hyperthyroidism

Scientific Title

The retrospective study of the correlation between I-123 uptakes and iodine concentrations of thyroid glands for patients with hyperthyroidism

Scientific Title:Acronym

The retrospective study of the correlation between I-123 uptakes and iodine concentrations of thyroid glands for patients with hyperthyroidism

Region

Japan


Condition

Condition

Hyperthyroidism

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to evaluate the correlation between I-123 uptakes in thyroid glands and iodine concentration calculated by DECT. We investigate whether DECT can assess thyroid function in patients with hyperthyroidism.

Basic objectives2

Others

Basic objectives -Others

A novel method for evaluation of thyroid function

Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Two examinations about thyroid function, including I-123 uptake and iodine concentrations by DECT, will reveal turnover of thyroid glands with two different aspects; 1) increasing uptake and 2) increasing excretion. DECT can predict thyroid function to evaluate excretion of iodine.

Key secondary outcomes



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

24 years-old <

Age-upper limit

79 years-old >

Gender

Female

Key inclusion criteria

- Patients with hyperthyroidism
- Treatment of I-131 ablation therapy
- Both I-123 scintigraphy and DECT before treatment

Key exclusion criteria

Inadequate iodine regulated diet
No scintigraphy nor DECT

Target sample size

13


Research contact person

Name of lead principal investigator

1st name Nakajima
Middle name
Last name Takahito

Organization

Gunma Graduate School of Medicine

Division name

Molecular Imaging Division

Zip code

3718911

Address

3-39-22, Showa, Maebashi, Gunma, Japan

TEL

027-220-8401

Email

sojin@gunma-u.ac.jp


Public contact

Name of contact person

1st name Nakajima
Middle name
Last name Takahito

Organization

Gunma University Hospital

Division name

Diagnostic radiology and nuclear medicine

Zip code

3718911

Address

3-39-22, Showa, Maebashi, Gunma, Japan

TEL

027-220-8401

Homepage URL


Email

sojin@gunma-u.ac.jp


Sponsor or person

Institute

Gunma University

Institute

Department

Personal name



Funding Source

Organization

Japan Science and Technology

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Gunma Graduate School of Medicine

Address

3-39-22, Showa, Maebashi, Gunma, Japan

Tel

+81272208401

Email

sojin@gunma-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

群馬大学医学部附属病院(群馬県)


Other administrative information

Date of disclosure of the study information

2016 Year 08 Month 01 Day


Related information

URL releasing protocol

men

Publication of results

Published


Result

URL related to results and publications

https://bmcmedimaging.biomedcentral.com/articles/10.1186/s12880-017-0216-6

Number of participants that the trial has enrolled

13

Results

Iodine concentration calculated by DECT can predict thyroid function.

Results date posted

2021 Year 03 Month 25 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

a. Graves' disease or hyperthyroid patients with a strong suspicion of Graves' disease
b. iodine restricted diet for more than 2 weeks before iodine ablation therapy

Participant flow

retrospective study

Adverse events

n.a.

Outcome measures

The correlation of 123I uptakes with iodine concentration evaluated by DECT

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2016 Year 06 Month 17 Day

Date of IRB

2016 Year 07 Month 01 Day

Anticipated trial start date

2016 Year 08 Month 01 Day

Last follow-up date

2019 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is published in BMC medical imaging.


Management information

Registered date

2016 Year 07 Month 25 Day

Last modified on

2021 Year 03 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026879


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name