UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016705 |
|---|---|
| Receipt number | 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 18:07:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
| Obstetrics 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)
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
yuya22wing@hotmail.com
Sponsor or person
Institute
Keio University School of Medicine, Department of Obstetrics & Gynecology
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
Keio University IRB
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan
Tel
03-5363-3611
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019362
