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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016705
Receipt No. R000019362
Scientific Title Evaluation of clinical efficacy of Magnetic Resonance Spectroscopy for gynecological pelvic abscess
Date of disclosure of the study information 2015/03/11
Last modified on 2019/09/08

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Basic information
Public title Evaluation of clinical efficacy of Magnetic Resonance Spectroscopy for gynecological pelvic abscess
Acronym Evaluation of clinical efficacy of MRS for gynecological pelvic abscess
Scientific Title Evaluation of clinical efficacy of Magnetic Resonance Spectroscopy for gynecological pelvic abscess
Scientific Title:Acronym Evaluation of clinical efficacy of MRS for gynecological pelvic abscess
Region
Japan

Condition
Condition Gynecological pelvic abscess
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Gynecological pelvic abscesses are a relatively common disease including pyometra, ovarian cyst infection and lymphcele infection after treatment of gynecological cancers.
The principals of treatment are administration of antibiotics and drainage. However, puncturing deep pelvic abscesses are technically challenging at times. In some cases, clinical improvement may be achieved without drainage, thus the choice of antibiotics is important.
MRI consists of the signals of protons developed in the magnetic field in the device. The frequencies of signals from protons attached to free water differ from those attached to other molecules. MRS is a technique to estimate the components of the lesions by utilizing the difference of frequency of each proton. For example, MRS has been reported to differentiate between necrotic tissues and relapsed lesions in brain tumors after radiation therapy, and detect lactic acid in abscesses, which is a sign suspicious of anaerobic infection.
In common practice, the type of antibiotic is decided based on clinical information, infection site and the estimated causative agent, and modified from the result of laboratory culture. When pelvic abscesses are challenging to puncture, MRS may induce useful information to management, if the MRS is useful to estimate the causative agent.
The aim of this study is to evaluate the diagnostic efficacy for abscess component and clinical utility of MRS, which is obtained in addition to usual MRI.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Diagnostic efficacy of MRS as for causative agents and results of biochemical examination of abscess contents
Key secondary outcomes Clinical efficacy of MRS for predicting clinical course (ex: for deciding indication of drainage)

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 In usual clinical practice, patients who are suspected as pelvic abscess undergo imaging examination such as MRI.In addition to usual scanning, the data of MRS will be obtained with deciding on the region of abscess detected by MRI. It takes about five minutes to gain additionally.
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 Patients with gynecological pelvic abscess in our hospital, who can undergo MRS.
Key exclusion criteria minors
patients who refuse scanning
patients whose data is not adequate
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Banno
Middle name
Last name Kouji
Organization Keio University Scool of Medicine
Division name Department of Obstetrics & Gynecology
Zip code 1408582
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL 03-3353-1211(ext.61723)
Email kbanno@z7.keio.jp

Public contact
Name of contact person
1st name Yuya
Middle name
Last name Nogami
Organization Keio University School of Medicine
Division name Department of Obstetrics & Gynecology
Zip code 1408582
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL 03-3353-1211(ext.61730)
Homepage URL
Email yuya22wing@hotmail.com

Sponsor
Institute Keio University School of Medicine, Department of Obstetrics & Gynecology
Institute
Department

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 Keio University IRB
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan
Tel 03-5363-3611
Email med-rinri-jimu@adst.keio.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
2015 Year 03 Month 11 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 17
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 02 Month 23 Day
Date of IRB
2015 Year 02 Month 23 Day
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
2019 Year 03 Month 20 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 03 Month 04 Day
Last modified on
2019 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019362

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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