UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029886
Receipt number R000030763
Scientific Title The utility of chemical exchange saturation transfer (CEST) imaging in female pelvis
Date of disclosure of the study information 2017/11/10
Last modified on 2021/11/11 14:44:53

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Basic information

Public title

The utility of chemical exchange saturation transfer (CEST) imaging in female pelvis

Acronym

The utility of CEST imaging in female pelvis

Scientific Title

The utility of chemical exchange saturation transfer (CEST) imaging in female pelvis

Scientific Title:Acronym

The utility of CEST imaging in female pelvis

Region

Japan


Condition

Condition

endometrial cancer, cervical cancer

Classification by specialty

Obstetrics and Gynecology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the utility of CEST imaging in female pelvis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1) to correlate signal intensity of APT imaging and histopathological findings in endometrial and cervical cancer
2) to correlate signal intensity of APT imaging and therapeutic response in cervical cancer

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1) equal or more than 20 years old
2) with contraindication to MRI

Key exclusion criteria

1) patients who cannot lie down for 30 min
2) pregnant patients
3) claustrophobia
4) chronic renal failure (eGFR 30mL/min/1.73m2)
5) patients who are considered not to be suitable for the research by research representative

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Shinya
Middle name
Last name Fujii

Organization

Tottori Univ.

Division name

Radiology

Zip code

6838504

Address

36-1, Nishi-cho, Yonago

TEL

0859-38-6637

Email

sfujii@med.tottori-u.ac.jp


Public contact

Name of contact person

1st name Shinya
Middle name
Last name Shinya

Organization

Tottori Univ.

Division name

Radiology

Zip code

6838504

Address

36-1, Nishi-cho, Yonago

TEL

0859-38-6637

Homepage URL


Email

sfujii@med.tottori-u.ac.jp


Sponsor or person

Institute

Tottori Univ.

Institute

Department

Personal name



Funding Source

Organization

None

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

Tottori Univ.

Address

Nishicho 36-1, Yonago

Tel

0859-38-6637

Email

sfujii@tottori-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

2017 Year 11 Month 10 Day


Related information

URL releasing protocol

https://link.springer.com/content/pdf/10.1007/s11604-021-01197-3.pdf

Publication of results

Published


Result

URL related to results and publications

https://link.springer.com/content/pdf/10.1007/s11604-021-01197-3.pdf

Number of participants that the trial has enrolled

63

Results

The APT max was significantly higher in type II carcinomas than in type I carcinomas (reader1, p=0.004; reader 2, p=0.014; respectively). However, APT mean showed no significant difference between type I and II carcinomas.

Results date posted

2021 Year 11 Month 11 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Between December 2017 and August 2020, 63 consecutive female patients underwent magnetic resonance imaging (MRI) because of the suspicion of endometrial cancer.

Participant flow

30 were excluded for the reasons such as the lesions were too small to be recognized on MRI.

Adverse events

None

Outcome measures

Two readers evaluated the magnetization transfer ratio at 3.5 ppm [MTRasym (3.5 ppm)] in each type of carcinoma. The average MTRasym (APTmean) and the maximum MTRasym (APTmax) were analyzed. The receiver operating characteristic (ROC) curve analysis was performed.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 10 Month 01 Day

Date of IRB

2018 Year 05 Month 22 Day

Anticipated trial start date

2017 Year 10 Month 01 Day

Last follow-up date

2020 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Nothing particular


Management information

Registered date

2017 Year 11 Month 08 Day

Last modified on

2021 Year 11 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030763


Research Plan
Registered date File name
2021/11/11 CEST申請書2021.doc

Research case data specifications
Registered date File name
2021/11/11 CEST申請書2021.doc

Research case data
Registered date File name
2021/11/15 症例.xlsx