UMIN-CTR Clinical Trial

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	2016 Year 10 Month 01 Day
Anticipated trial start date	2016 Year 11 Month 10 Day
Last follow-up date	2021 Year 03 Month 31 Day
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	2020 Year 05 Month 07 Day

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