UMIN-CTR Clinical Trial

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