UMIN-CTR Clinical Trial

Public title

Lymphatic flow changes after sentinel lymph node biopsy in primary cutaneous malignant melanoma

Acronym

Lymphatic flow changes

Scientific Title

Lymphatic flow changes after sentinel lymph node biopsy in primary cutaneous malignant melanoma

Scientific Title:Acronym

Lymphatic flow changes

Region

Japan

Condition

Malignant melanoma

Classification by specialty

Dermatology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To study changes of lymphatic flow from sites of primary tumors to regional lymph nodes after sentinel lymph node biopsy in Japanese patients with primary cutaneous malignant melanoma.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II

Primary outcomes

Lymphatic flow changes after sentinel lymph node biopsy. The times between SLNB and the second NIR imaging were from 22 days to 786 days (average: 101.6 days).

Key secondary outcomes

Safety and efficacy of sentinel lymph node biopsy

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

The agent for the NIR imaging was prepared as follows. Human serum albumin (5 mg), indocyanine green (ICG; Diano-green; Daichi Pharmaceutical, Tokyo, Japan)(0.6 mg) and Patent Blue (Wako Pure Chemical Industries, Ltd.) (6 mg) were dissolved in 1 mL of pure water. The ICG was visualized using a fluorescence imaging system (Photo Dynamic Eye; PDE, Hamamatsu Photonics, Japan) that includes a small charge-coupled-device camera with an integrated near-infrared (NIR) LED light source (energy: 4 mW; wavelength: 760 nm). An 820-nm band-path filter was employed to collect NIR radiation and to reject visible light. The fluorescence signals were sent to a digital video processor for display on a TV monitor. Videos were taken of the dye-injection process, the pulsing of collecting vessels and the overall lymphatic vessels.
Second-time NIR imaging of lymphatic flow after SLNB were also performed.
The times between SLNB and the second NIR imaging were from 22 days to 786 days (average: 101.6 days).
NIR imaging after SLNB was also performed using the same NIR imaging methods as those of the first-time NIR imaging before SLNB, described above.

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Primary cutaneous malignant melanoma lesions with more than 1mm thickness or lesions estimated to be at Clark level IV, V.
The tumor thickness was estimated by clinical features, dermoscopic findings and images of echogram, CT or MRI.

Key exclusion criteria

Patients with PCMM apparently <1.0 mm thick clinically were excluded. Patients with apparent regional lymph node involvement were excluded. Patients in whom apparent metastatic lesions were found by physical and imaging examinations were also excluded.

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Masashi Akiyama

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Dermatology

Zip code

Address

65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan

TEL

052-744-2314

Email

makiyama@med.nagoya-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Kenji Yokota

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Dermatology

Zip code

Address

65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan

TEL

052-744-2314

Homepage URL

Email

kyokota@med.nagoya-u.ac.jp

Institute

Nagoya University Graduate School of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

10

Month

14

Day

URL releasing protocol

Publication of results

Partially published

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

Recruitment status

Open public recruiting

Date of protocol fixation

2009

Year

07

Month

13

Day

Date of IRB

Anticipated trial start date

2009

Year

08

Month

13

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

10

Month

14

Day

Last modified on

2015

Year

10

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022351