UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028645
Receipt number R000032723
Scientific Title Test-retest reliability of a quantitative bone SPECT/CT
Date of disclosure of the study information 2017/09/01
Last modified on 2022/03/22 12:43:45

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Basic information

Public title

Test-retest reliability of a quantitative bone SPECT/CT

Acronym

Test-retest reliability of a quantitative bone SPECT/CT

Scientific Title

Test-retest reliability of a quantitative bone SPECT/CT

Scientific Title:Acronym

Test-retest reliability of a quantitative bone SPECT/CT

Region

Japan


Condition

Condition

Prostate cancer

Classification by specialty

Urology Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate test-retest reliability of the quantitative value measured by quantitative bone SPECT/CT

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

test-retest reliability

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

Device,equipment

Interventions/Control_1

Bone scintigraphy and SPECT/CT

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

Key inclusion criteria

#1 Written informed consent was acquired
#2 Twenty years or older
#3 Prostate cancer was diagnosed or suspected
#4 Bone scintigraphy was performed or planned
#5 Second bone scintigraphy can be performed in 4-10 days after the first bone scan numbered #4

Key exclusion criteria

#1 Unable to keep supine position for 1 hour
#2 Anti-cancer drug, hormone drug, radionuclide treatment or radiation therapy for bone lesion was planned during 2 bone scans
#3 Person in charge considered inappropriate to include to this study

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Tomohiko
Middle name
Last name Yamane

Organization

Saitama Medical University International Medical Center

Division name

Nuclear Medicine

Zip code

3501298

Address

Yamane 1397-1, Hidaka

TEL

042-984-4111

Email

yamane_t@saitama-med.ac.jp


Public contact

Name of contact person

1st name Yamane
Middle name
Last name Tomohiko

Organization

Saitama Medical University International Medical Center

Division name

Nuclear Medicine

Zip code

3501298

Address

Yamane 1397-1, Hidaka

TEL

042-984-4111

Homepage URL


Email

yamane_t@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University

Institute

Department

Personal name



Funding Source

Organization

Saitama Medical University International Medical Center

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Saitama Medical University International Medical Center IRB

Address

Yamane 1397-1, Hidaka

Tel

042-984-4111

Email

chikens@saitama-med.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 09 Month 01 Day


Related information

URL releasing protocol

https://link.springer.com/article/10.1007/s12149-020-01568-2

Publication of results

Published


Result

URL related to results and publications

https://link.springer.com/article/10.1007/s12149-020-01568-2

Number of participants that the trial has enrolled

13

Results

The ICCs were 0.968 [95% CI (0.959, 0.975)] for SUVmax and 0.976 [95% CI (0.969, 0.981)] for SUVpeak. The RCs of the relative difference were 30.7% for SUVmax and 27.6% for SUVpeak, and the MAPDs of all lesions were 12.3% for SUVmax and 11.5 for SUVpeak. The RCs and the MAPDs showed comparable value with the previous report regarding repeatability studies on PET.

Results date posted

2022 Year 03 Month 22 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients with prostate cancer planning to receive bone SPECT/CT for the evaluation of bone abnormality between August 2017 and September 2019.

Participant flow

Recruited patients who matched the criteria.

Adverse events

No adverse events

Outcome measures

Intraclass correlation coefficient (ICC), repeatability coefficient (RC), and mean absolute percentage difference (MAPD)

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 09 Month 01 Day

Date of IRB

2017 Year 09 Month 06 Day

Anticipated trial start date

2017 Year 09 Month 30 Day

Last follow-up date

2019 Year 12 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

2017 Year 08 Month 12 Day

Last modified on

2022 Year 03 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032723


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name