UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000031637
Receipt No. 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 2019/09/10

* 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 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
Obsterics 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
Email 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
Email y.matoba0212@gmail.com

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
Email 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 Main results already published
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
2019 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036012

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.