None listed
Conditions
Interventions
Drug : For the resection of the target lesion, surgical marking is performed using Luminomark, 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. Thyroid nodules or follicular tumors that are difficult to localize with conventional methods such as CT, ultrasound, and scans, but require surgery 2. Recurrent or primary thyroid cancer for which surgery is planned, although localization is difficult with conventional methods such as CT, ultrasound, and scan 3. Parathyroid adenoma or cancer that is difficult to localize with conventional methods such as CT, ultrasound, or scan, but surgery is planned 4. Cervical tumors that are difficult to localize with conventional methods such as CT, ultrasound, and scans, but require surgery 5. Patients between the ages of 19 and 80 6. 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 with at least 12 months of amenorrhea are considered non-fertile women) 4. Patients with mental illness, those with a history of alcoholism or drug abuse 5. A person who is judged by the researcher to be unfit to participate in the research for other reasons 6. Patients with a history of hypersensitivity to active ingredients and excipients of investigational drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the success rate of topical labeling. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the time required to excise the first target lesion, evaluate the total lesion excision surgery time, evaluate the pigmentation rate, evaluate the rate of postoperative side effects, evaluate safety data (vital signs, adverse events) | — |
Countries
Korea, Republic of
Contacts
Public ContactSu yeon Hwang
National Cancer Center
Outcome results
None listed