Development of the Surgical Technique Using Radioactive Fluorescent Dual Contrast Agent for Intraoperative Sentinel Lymph Node Detection in Lung Cancer Patients
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Clinical chemistry examination-4
研究概览
简要总结
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.
详细描述
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 (99mTc-MSA-ICG) to detect sentinel lymph nodes for patient-specific minimally invasive surgery.
To analyze the effectiveness of radioactive fluorescent dual contrast agent (99mTc-MSA-ICG) for detecting sentinel lymph node, total 10 lung cancer patients will participate in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •congestive heart failure with symptoms
- •New York Heart Association III/IV Class Heart Disease
- •Unstable angina
- •Symptom or unregulated heart arrhythmia
- •Myocardial infarction within the past three months
- •QT interval (QTcF) using Fridricia calibration
- •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
研究组 & 干预措施
99mTc-MSA-ICG injection
99mTc-MSA-ICG injection
1mCi of 99mTc
1mg of MSA 0.1mg of ICG Total 1cc injection volume at 2 hours before the surgery
干预措施: 99mTc-MSA-ICG (Drug)
结局指标
主要结局
Clinical chemistry examination-4
时间窗: postoperative day 5
Carrying out the clinical chemistry examination(CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic) to check the drug-related safety in 10 lung cancer patients on POD 5 (mg/dL)
Clinical chemistry examination-1 (CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic)
时间窗: Within two weeks before surgery
Carrying out the clinical chemistry examination(CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery. (mg/dL)
Clinical chemistry examination-2
时间窗: postoperative day 0
Carrying out the clinical chemistry examination(CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic) to check the drug-related safety in 10 lung cancer patients on postoperativeday(POD) 0 (mg/dL)
Clinical chemistry examination-5
时间窗: within two weeks before surgery
Carrying out the clinical chemistry examination (Procalcitonin) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery. (ng/mL)
Clinical chemistry examination-6
时间窗: postoperative day 0
Carrying out the clinical chemistry examination (Procalcitonin) to check the drug-related safety in 10 lung cancer patients on POD 0 (ng/mL)
Clinical chemistry examination-12
时间窗: postoperative day 5
Carrying out the clinical chemistry examination (AST,ALT,LDH,ALP,GGT) to check the drug-related safety in 10 lung cancer patients on POD 5 (IU/L)
Clinical chemistry examination-13
时间窗: within two weeks before surgery
Carrying out the clinical chemistry examination (Na, K, Cl) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (mmol/L)
Clinical chemistry examination-14
时间窗: postoperative day 0
Carrying out the clinical chemistry examination (Na, K, Cl) to check the drug-related safety in 10 lung cancer patients on POD 0 (mmol/L)
Hematology examination-5
时间窗: within two weeks before surgery
Carrying out the clinical hematology examination (hemoglobin, MCHC) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (g/dL)
Hematology examination-7
时间窗: postoperative day 1
Carrying out the clinical hematology examination (hemoglobin, MCHC) to check the drug-related safety in 10 lung cancer patients on POD 1 (g/dL)
Hematology examination-9
时间窗: within two weeks before surgery
Carrying out the clinical hematology examination (hematocrit, WBC differential) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (%)
Hematology examination-10
时间窗: postoperative day 0
Carrying out the clinical hematology examination (hematocrit, WBC differential) to check the drug-related safety in 10 lung cancer patients on POD0 (%)
Hematology examination-11
时间窗: postoperative day 1
Carrying out the clinical hematology examination (hematocrit, WBC differential) to check the drug-related safety in 10 lung cancer patients on POD1 (%)
Hematology examination-13
时间窗: within two weeks before surgery
Carrying out the clinical hematology examination (RBC count, WBC count, platelet count) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (10³/μl)
Hematology examination-20
时间窗: postoperative day 5
Carrying out the clinical hematology examination (MCV) to check the drug-related safety in 10 lung cancer patients on POD 5 (fL)
Clinical chemistry examination-3
时间窗: postoperative day 1
Carrying out the clinical chemistry examination(CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic) to check the drug-related safety in 10 lung cancer patients on POD 1 (mg/dL)
Clinical chemistry examination-8
时间窗: postoperative day 5
Carrying out the clinical chemistry examination (Procalcitonin) to check the drug-related safety in 10 lung cancer patients on POD 5 (ng/mL)
Clinical chemistry examination-9
时间窗: within two weeks before surgery
Carrying out the clinical chemistry examination (AST,ALT,LDH,ALP,GGT) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (IU/L)
Clinical chemistry examination-10
时间窗: postoperative day 0
Carrying out the clinical chemistry examination (AST,ALT,LDH,ALP,GGT) to check the drug-related safety in 10 lung cancer patients on POD 0 (IU/L)
Clinical chemistry examination-15
时间窗: postoperative day 1
Carrying out the clinical chemistry examination (Na, K, Cl) to check the drug-related safety in 10 lung cancer patients on POD 1 (mmol/L)
Hematology examination-2
时间窗: postoperative day 0
Carrying out the clinical chemistry examination (Mg) to check the drug-related safety in 10 lung cancer patients on POD 0 (mEq/L)
Hematology examination-3
时间窗: postoperative day 1
Carrying out the clinical chemistry examination (Mg) to check the drug-related safety in 10 lung cancer patients on POD 1 (mEq/L)
Hematology examination-4
时间窗: postoperative day 5
Carrying out the clinical chemistry examination (Mg) to check the drug-related safety in 10 lung cancer patients on POD 5 (mEq/L)
Hematology examination-12
时间窗: postoperative day 5
Carrying out the clinical hematology examination (hematocrit, WBC differential) to check the drug-related safety in 10 lung cancer patients on POD5 (%)
Hematology examination-14
时间窗: postoperative day 0
Carrying out the clinical hematology examination (RBC count, WBC count, platelet count) to check the drug-related safety in 10 lung cancer patients on POD0 (10³/μl)
Hematology examination- 21
时间窗: within two weeks before surgery
Carrying out the clinical hematology examination (MCH) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (pg)
Hematology examination- 22
时间窗: postoperative day 0
Carrying out the clinical hematology examination (MCH) to check the drug-related safety in 10 lung cancer patients and POD 0 (pg)
Clinical chemistry examination-7
时间窗: postoperative day 1
Carrying out the clinical chemistry examination (Procalcitonin) to check the drug-related safety in 10 lung cancer patients on POD 1 (ng/mL)
Clinical chemistry examination-11
时间窗: postoperative day 1
Carrying out the clinical chemistry examination (AST,ALT,LDH,ALP,GGT) to check the drug-related safety in 10 lung cancer patients on POD 1 (IU/L)
Clinical chemistry examination-16
时间窗: postoperative day 5
Carrying out the clinical chemistry examination (Na, K, Cl) to check the drug-related safety in 10 lung cancer patients on POD 5 (mmol/L)
Hematology examination-1
时间窗: within two weeks before surgery
Carrying out the clinical chemistry examination (Mg) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery(mEq/L)
Hematology examination-6
时间窗: postoperative day 0
Carrying out the clinical hematology examination (hemoglobin, MCHC) to check the drug-related safety in 10 lung cancer patients on POD 0 (g/dL)
Hematology examination-8
时间窗: postoperative day 5
Carrying out the clinical hematology examination (hemoglobin, MCHC) to check the drug-related safety in 10 lung cancer patients on POD 5 (g/dL)
Hematology examination-18
时间窗: postoperative day 0
Carrying out the clinical hematology examination (MCV) to check the drug-related safety in 10 lung cancer patients on POD 0 (fL)
Hematology examination- 24
时间窗: postoperative day 5
Carrying out the clinical hematology examination (MCH) to check the drug-related safety in 10 lung cancer patients on POD 5 (pg)
Hematology examination- 28
时间窗: postoperative day 5
Carrying out the clinical hematology examination (PT, aPTT) to check the drug-related safety in 10 lung cancer patients on POD 5 (sec)
Effective dose measurement
时间窗: Up to five days after surgery
Hematology examination-15
时间窗: postoperative day 1
Carrying out the clinical hematology examination (RBC count, WBC count, platelet count) to check the drug-related safety in 10 lung cancer patients on POD1 (10³/μl)
Hematology examination-16
时间窗: postoperative day 5
Carrying out the clinical hematology examination (RBC count, WBC count, platelet count) to check the drug-related safety in 10 lung cancer patients on POD5 (10³/μl)
Hematology examination-17
时间窗: within two weeks before surgery
Carrying out the clinical hematology examination (MCV) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery(fL)
Hematology examination-19
时间窗: postoperative day 1
Carrying out the clinical hematology examination (MCV) to check the drug-related safety in 10 lung cancer patients on POD 1(fL)
Hematology examination- 27
时间窗: postoperative day 1
Carrying out the clinical hematology examination (PT, aPTT) to check the drug-related safety in 10 lung cancer patients on POD 1 (sec)
Hematology examination- 23
时间窗: postoperative day 1
Carrying out the clinical hematology examination (MCH) to check the drug-related safety in 10 lung cancer patients on POD 1 (pg)
Check for changes of urinalysis-3
时间窗: postoperative day 1
Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) on POD 1(number)
Check for changes of urinalysis-4
时间窗: postoperative day 5
Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) on POD 5 (number)
Check for changes of urinalysis-7
时间窗: postoperative day 1
Carrying out the urinalysis examination(ketone, blood, protein, urobilinogen, nitrate in urine) to check the drug-related safety in 10 lung cancer patients on POD 1 (0 or +1)
Hematology examination- 25
时间窗: within two weeks before surgery
Carrying out the clinical hematology examination (PT, aPTT) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (sec)
Hematology examination- 26
时间窗: postoperative day 0
Carrying out the clinical hematology examination (PT, aPTT) to check the drug-related safety in 10 lung cancer patients on POD 0 (sec)
Check for changes of urinalysis-1
时间窗: within two weeks before surgery
Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) within two weeks before surgery (number)
Check for changes of urinalysis-2
时间窗: postoperative day 0
Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) on POD 0 (number)
Check for changes of urinalysis-5
时间窗: within two weeks before surgery
Carrying out the urinalysis examination(ketone, blood, protein, urobilinogen, nitrate in urine) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (0 or +1)
Check for changes of urinalysis-6
时间窗: postoperative day 0
Carrying out the urinalysis examination(ketone, blood, protein, urobilinogen, nitrate in urine) to check the drug-related safety in 10 lung cancer patients on POD 0 (0 or +1)
Check for changes of urinalysis-8
时间窗: postoperative day 5
Carrying out the urinalysis examination(ketone, blood, protein, urobilinogen, nitrate in urine) to check the drug-related safety in 10 lung cancer patients on POD 5 (0 or +1)
Check for changes of urinalysis-9
时间窗: within two weeks before surgery
Carrying out the urinalysis examination(WBC in urine) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery(4 - 0 / HPF
Check for changes of urinalysis-10
时间窗: postoperative day 0
Carrying out the urinalysis examination(WBC in urine) to check the drug-related safety in 10 lung cancer patients on POD 0 (4 - 0 / HPF)
Check for changes of urinalysis-11
时间窗: postoperative day 1
Carrying out the urinalysis examination(WBC in urine) to check the drug-related safety in 10 lung cancer patients on POD 1 (4 - 0 / HPF)
Check for changes of urinalysis-12
时间窗: postoperative day 5
Carrying out the urinalysis examination(WBC in urine) to check the drug-related safety in 10 lung cancer patients on POD 5 (4 - 0 / HPF)
Observation of the irritable adverse reaction
时间窗: Up to 2 hours after drug injection
Observation of the irritable adverse reaction (Urticaria, angioedema, allergic rhinitis, anaphylaxis, exanthermatous eruption, fixed drug eruption, acneiform eruption, purpura eruption, urticarial eruption, bullous eruption, lichenoid eruption, Stevens-Johnson syndrom, acute generalized exanthematous pustulosis, toxic epidermal necrolysis) to check the drug-related safety in 10 lung cancer patients
次要结局
- Confirm the false negative rate(Through study completion, an average of 1 year)
- Confirm the sentinel lymph node identification rate(Through study completion, an average of 1 year)
研究者
Hyun Koo Kim
Professor of Thoracic and Cardiovascular Surgery
Korea University Guro Hospital