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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024636
Receipt No. R000028342
Scientific Title Indocyanine green and infrared fluorescence in sentinel lymph node mapping for endometrial cancer and cervical cancer: An exploratory study
Date of disclosure of the study information 2016/11/01
Last modified on 2019/05/03

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Basic information
Public title Indocyanine green and infrared fluorescence in sentinel lymph node mapping for endometrial cancer and cervical cancer: An exploratory study

Acronym Indocyanine green and infrared fluorescence in sentinel lymph node mapping for endometrial cancer and cervical cancer: An exploratory study
Scientific Title Indocyanine green and infrared fluorescence in sentinel lymph node mapping for endometrial cancer and cervical cancer: An exploratory study

Scientific Title:Acronym Indocyanine green and infrared fluorescence in sentinel lymph node mapping for endometrial cancer and cervical cancer: An exploratory study
Region
Japan

Condition
Condition Cervical cancer
Endometrial cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to establish sentinel lymph node (SLN) mapping using indocyanine green to perform minimally invasive surgery by omitting systematic lymph node dissection.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Detection rate of SLN
Key secondary outcomes Sensitivity, false negative rate, and negative predictive value of SLN
Accuracy of pathological diagnosis during surgery
Adverse effects
The number and location of the SLNs

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
Medicine
Interventions/Control_1 The concentration of indocyanine green (ICG) is 2.5 mg/mL. For each patient, a 25 mg vial with ICG powder is diluted in 10 mL of sterile water. We routinely inject 4 mL of the ICG solution into the cervix divided in the 3- and 9-O'clock positions, 1 mL deep into the stroma and 1 mL submucosally on the right and the left of the cervix. Additionally, in patients with endometrial cancer, 2 mL of ICG is injected into the myometrium divided into the lower uterine segment and uterine fundus (midline subserosa). A near-infrared fluorescence imaging system Photodynamic Eye (PDE-Neo, Hamamatsu Photonics, Hamamatsu, Japan) is used to detect the SNLs.


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
70 years-old >=
Gender Female
Key inclusion criteria 1. Patients with endometrial cancer who are scheduled for retroperitoneal lymph node dissection or with stage 1A2 to 2A1 cervical cancer based on the International Federation of Gynecology and Obstetrics guidelines.
2. Over 20 years of age and under 70 years of age
3. Eastern Cooperative Oncology Group Performance status score 0-1
4. Patients who provides written informed consent
Key exclusion criteria 1. Prior medical history of chemical sensitivity to indocyanine green
2. Detection of obvious lymph node swelling using CT or MRI
3. Extra-uterine dissemination
4. Patients on dialysis
5. Patients determine to be ineligible for any other reason by the physician in-charge
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Akira
Middle name
Last name Mitsuhashi
Organization Graduate School of Medicine, Chiba University
Division name Reproductive Medicine
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL 043-222-7171
Email antira@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Akira
Middle name
Last name Mitsuhashi
Organization Graduate School of Medicine, Chiba University
Division name Reproductive Medicine
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL 043-222-7171
Homepage URL
Email antira@faculty.chiba-u.jp

Sponsor
Institute Ciba University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Chiba University Hospital Institutional Review Board
Address 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
Tel 043-222-7171
Email hanaoka.hideki@faculty.chiba-u.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
2016 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Open public recruiting
Date of protocol fixation
2016 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 30 Day
Last modified on
2019 Year 05 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028342

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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