Development of the Surgical Technique Using Radioactive Fluorescent Dual Contrast Agent for Intraoperative Sentinel Lymph Node Detection in Lung Cancer Patients
Overview
- Phase
- Early Phase 1
- Intervention
- 99mTc-MSA-ICG
- Conditions
- Lung Cancer
- Sponsor
- Korea University Guro Hospital
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Clinical chemistry examination-4
- Last Updated
- 4 years ago
Overview
Brief 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.
Detailed Description
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.
Investigators
Hyun Koo Kim
Professor of Thoracic and Cardiovascular Surgery
Korea University Guro Hospital
Eligibility 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
- •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
Arms & Interventions
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
Intervention: 99mTc-MSA-ICG
Outcomes
Primary Outcomes
Clinical chemistry examination-4
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Up to five days after surgery
Hematology examination-15
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Secondary Outcomes
- 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)