UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031637 |
|---|---|
| Receipt number | R000036012 |
| Scientific Title | Evaluation of the efficacy of hysteroscopic photodynamic diagnosis using 5-aminolevulinic acid for diseases in the uterine cavity. |
| Date of disclosure of the study information | 2018/03/08 |
| Last modified on | 2020/02/04 15:25:08 |
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Basic information
Public title
Evaluation of the efficacy of hysteroscopic photodynamic diagnosis using 5-aminolevulinic acid for diseases in the uterine cavity.
Acronym
Evaluation of hysteroscopic photo dynamic diagnosis for the diseases in the uterine cavity.
Scientific Title
Evaluation of the efficacy of hysteroscopic photodynamic diagnosis using 5-aminolevulinic acid for diseases in the uterine cavity.
Scientific Title:Acronym
Evaluation of hysteroscopic photo dynamic diagnosis for the diseases in the uterine cavity.
Region
| Japan |
Condition
Condition
diseases in the uterine cavity
(ex: uterine myoma, endometrial polyp, uterine corpus cancer, endometrial hyperplasia)
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There are some methods to diagnose malignant diseases in the uterine cavity (ex. MRI, CT, and hysteroscopy). However, the sensitivity of these methods for malignant diseases is not high. This study is to evaluate the efficacy of the hysteroscopic photodynamic diagnosis using 5-aminolevulinic acid for malignant diseases in the uterine cavity.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy of the hysteroscopic photodynamic diagnosis using 5-ALA for malignant diseases.
Key secondary outcomes
The relation of the histologic type and the strength of the fluorescence.
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
Prevention
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
3 hours before operation, patients will take the 5-aminolevulinic acid(20 mg/kg) once.
3 hours later, they will be performed photodynamic diagnosis under the hysteroscopy. During the operation, they will be observed with the white light first. After that, they will be observed with the excitation light. We will record all lesions and we will judge whether the lesion is positive, weakly positive or negative for the photodynamic diagnosis. After judgement, we will resect positive and weakly positive lesions under the excitation light first. After that, we'll resect other lesions under the white light if we can find any in addition. When the resection is finished, we will do curettage if we need. We will investigate all samples histopathologically.
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 who have diseases in the uterine cavity (including both of benign and malignant).
Patients who plan to undergo hysteroscopic operation for those diseases at the Department of Obstetrics and Gynecology of Keio University Hospital
Key exclusion criteria
1. under 20 years old
2. BMI>30
Patients who have
3. the medical history of full endometrial curettage in recent 14 days.
4. the allergic history for the analog of the porphyrin.
5. the history of porphyria
6. the medicine that is known for the cause of photosensitivity (ex. tetracycline antibacterial agent, medicine of sulfonamide, new quinolone antibacterial agent, hypericin and St.John's Wort.
7. the possibility of being pregnant or breast feeding
8. diabetes mellitus and/or hyperlipidemia which is not controlled.
9. other endocrine diseases which are not controlled.
10. Patients who are considered inadequate for this trial by the principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kouji |
| Middle name | |
| Last name | Banno |
Organization
Keio University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
160-0016
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
kbanno@keio.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Matoba |
Organization
Keio University School of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
160-0016
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
y.matoba0212@gmail.com
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Japanese Foundation for Research and Promotion of Endoscopy
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
SBI Pharmaceuticals Co., Ltd.
MC Medical, Inc.
IRB Contact (For public release)
Organization
Certified Review Board of Keio
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-5363-3503
med-nintei-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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
34
Results
The sensitivity and specificity of 5ALA-PDD for diagnosis of malignancy in the uterine cavity were 93.4% and 51.9%, respectively.
Results date posted
| 2019 | Year | 09 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Adverse events were found in 6 subjects (17.6%) from after 5ALA oral administration to before hysteroscopic resection: nausea in 3 (8.8%), vomiting in 1 (2.9%), headache in 1 (2.9%), and malaise in 1 (2.9%); and in 8 subjects (20.6%) from after surgery to hospital discharge: erythema in 4 (11.8%), nausea in 1 (2.9%), vomiting in 1 (2.9%), headache in 1 (2.9%), and hypotension in 1 (2.9%). Adverse events one month after surgery occurred in 15 subjects (44.1%): increased aspartate aminotransferase (AST) in 5 (14.7%), increased alanine aminotransferase (ALT) in 2 (5.9%), increased creatinine in 2 (5.9%), and anemia in 6 (17.6%). Grade 2 anemia occurred in one subject; all others were grade 1 (Table 5). All adverse events were treated with palliative care and with full resolution to baseline.
Outcome measures
To identify the sensitivity and specificity of 5ALA-PDD for intrauterine malignancies (atypical endometrial hyperplasia and endometrial cancer)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 08 | Day |
Last modified on
| 2020 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036012
