UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024636 |
|---|---|
| Receipt number | 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 | 2020/05/07 07:53:17 |
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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
| Obstetrics 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
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
antira@faculty.chiba-u.jp
Sponsor or person
Institute
Ciba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028342
