UMIN-CTR Clinical Trial

Basic information
Public title	Sentinel lymph node detection using radioisotopes in skin cancer
Acronym	Sentinel lymph node detection in skin cancer
Scientific Title	Sentinel lymph node detection using radioisotopes in skin cancer
Scientific Title:Acronym	Sentinel lymph node detection in skin cancer
Region	Japan

Condition
Condition	metastatic skin cancer
Classification by specialty	Dermatology Radiology Plastic surgery Not applicable
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Study of the significance of sentinel lymph node search inmetastatic skin cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Identification and localization of sentinel lymph nodes
Key secondary outcomes	Decision of the cut-off value of lymphatic transit rate indicating negative nodal metastasis

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	Intracutaneous injections of Technetium-99m-phytate (6x18.5MBq) around the tumor at lymphoscintigraphy
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients who were diagnosed with metastatic skin cancer based on histopathological examination. 2. From the results of medical history, physical findings, blood, examination, and urine test, the patients who had no serious complications that could not put them under general anesthesia or lumbar anesthesia. 3. Patients who gave written informed consent.
Key exclusion criteria	1. Patients who are pregnant. Patients who are breast-feeding. Patients with drug allergy to Technetium-99m -phytate. 2. Patients who did not give written informed consent. 3. Attending physician judged that the patients were inappropriate to participate in the study.
Target sample size	240

Research contact person
Name of lead principal investigator	1st name Masao Middle name Last name Fujiwara
Organization	Hamamatsu University School of Medicine
Division name	Plastic and Reconstructive Surgery
Zip code	431-3192
Address	1-20-1 Handayama, Hamamatsu, Shizuoka 431-3192
TEL	053-435-2798
Email	jufoasam@hama-med.ac.jp

Public contact
Name of contact person	1st name Masao Middle name Last name Fujiwara
Organization	Hamamatsu University School of Medicine
Division name	Plastic and Reconstructive Surgery
Zip code	431-3192
Address	1-20-1 Handayama, Hamamatsu, Shizuoka 431-3192
TEL	053-435-2798
Homepage URL
Email	jufoasam@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	The Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Hamamatsu University School of Medicine
Address	1-20-1 Handayama, Hamamatsu, Shizuoka 431-3192, Japan
Tel	053-435-2680, 2972
Email	rinri@hama-med.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	浜松医科大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 12 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	Enrolling by invitation
Date of protocol fixation	2016 Year 07 Month 12 Day
Date of IRB	2016 Year 07 Month 05 Day
Anticipated trial start date	2022 Year 03 Month 31 Day
Last follow-up date	2022 Year 07 Month 31 Day
Date of closure to data entry	2023 Year 03 Month 31 Day
Date trial data considered complete	2023 Year 03 Month 31 Day
Date analysis concluded	2023 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 07 Month 12 Day
Last modified on	2019 Year 07 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026148