SLN Detection With Tc-MSA-ICG in Lung Cancer Patients

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

It is necessary to develop a technique of sentinel lymph node detection using radioactive fluorescent dual contrast agent consisting targetable albumin for specific marker to accurately determine whether or not the sentinel lymph nodes have metastasized or non-metastasized. Therefore, investigators would like to conduct a clinical trial to evaluate the effectiveness of radioactive fluorescent dual contrast agent to detect sentinel lymph nodes for patient-specific minimally invasive surgery.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Korea University Guro Hospital

Criteria

Inclusion Criteria:

Preoperative examinations (chest CT, PET/CT, bone scan, brain MRI) diagnosed the clinical stage as T1a or T1b with the size the cancer less than 2 cm and adenocarcinoma or square cell carcinoma through preoperative biopsy, with no lymph node or other diseases and lung disease. A person who meets the conditions described below and does not fall under the exclusion criteria is selected as an adult.

• Eastern cooperative oncology group (ECOG) performance scale: 0~2

• White blood cell count ≥ 3,000/㎣ and ≤ 12,000/㎣

• Neutrophil count ≥ 1,500/㎣

• Platelet count ≥ 100,000/㎣

• AST, ALT ≤ 2.5 times the upper limit

• Total bilirubin ≤ 2.5 times the upper limit

• Serum creatinine ≤ 1.5 time the upper limit

Exclusion Criteria:

• Those who do not agree or refuse to participate in the research

• A person who is not suitable for general anesthesia

• A person with a clinically significant acute or unstable condition

• A person with the following serious heart disease

1. congestive heart failure with symptoms

2. New York Heart Association III/IV Class Heart Disease

3. Unstable angina

4. Symptom or unregulated heart arrhythmia

5. Myocardial infarction within the past three months

6. QT interval (QTcF) using Fridricia calibration

7. Family history of long QT syndrome

• Those who cannot be scanned (e.g., patients with claustrophobia, ect.)

• A person who received a therapeutic radiation dose within four weeks prior to participation in the study ([18F]FDG has a half-life of 109 minutes, so after 18.2 hours, 99mTc-MDP has a half-life of 6 hours, that is after 2.5 days)

• A person who is being administered drugs such as a drug metabolic enzyme inducer or inhibitor within four weeks before participating in the study

• A person who has overreacted or had side effects on clinical research medications (ICG or 99mTc).

• Patients with closed diseases

• Patients with iodine intolerance

• In the case of pregnant women/feeding mothers or pregnant women, those who do not agree to the use of appropriate contraception methods during the research period;

• A person who participated in another clinical study within 12 weeks before participating in the study and administered clinical research medications or received medical device procedures for clinical research.

• Those who are unfit to participate in this clinical study in the judgment of the research manager