None listed
Conditions
Interventions
Drug : For the resection of the target lesion, surgical marking is performed using Lumino Mark, which is designed as an injection formulation of indocyanine green, and the procedure is performed.
Test
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A patient who has been diagnosed with operable recurrent differentiated thyroid carcinoma and is scheduled for resection-cervical clearing 2. Patients between the ages of 20 and 80 3. Patients who voluntarily decided to participate in this clinical study and signed the written informed consent
Exclusion criteria
Exclusion criteria: 1. Those with a history of allergy to ICG (Indocyanine Green) 2. Pregnant and lactating women 3. Women of childbearing potential who are expected to become pregnant (menopausal women who have been amenorrheic for at least 12 months regard) 4. Patients with mental illness, those with a history of alcoholism or drug abuse 5. Those who have participated in other clinical trials within 6 months of participating in this study 6. A person who is judged by the researcher to be unfit to participate in the research for other reasons 7. Patients with a history of hypersensitivity to active ingredients and excipients of investigational drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Evaluate the success rate of local marking. | — |
Secondary
| Measure | Time frame |
|---|---|
| 2) Evaluate the time required to excise the first target lesion. 3) Evaluate the total lesion excision surgery time. 4) Evaluate the pigmentation rate. 5) Evaluate the rate of side effects after surgery. 6) Evaluate safety data (vital signs, adverse events). | — |
Countries
Korea, Republic of
Contacts
Public ContactSu yeon Hwang
National Cancer Center
Outcome results
None listed