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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 99mTc-MSA-ICG injection | Experimental | 99mTc-MSA-ICG injection 1mCi of 99mTc 1mg of MSA 0.1mg of ICG Total 1cc injection volume at 2 hours before the surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 99mTc-MSA-ICG | Drug | Intratumoral injection of 99mTechnetium-manosylated albumin-indocyanine green to lung cancer patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical chemistry examination-1 (CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic) | 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) | Within two weeks before surgery |
| Clinical chemistry examination-2 | 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) | postoperative day 0 |
| Clinical chemistry examination-3 | 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) | postoperative day 1 |
| Clinical chemistry examination-4 | 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) | postoperative day 5 |
| Clinical chemistry examination-5 | 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) | within two weeks before surgery |
| Clinical chemistry examination-6 |
| Measure | Description | Time Frame |
|---|---|---|
| Confirm the sentinel lymph node identification rate | Calculation the percentage of cancer cells found in pathological test among sentinel lymph nodes where fluorescent or nuclear signal are detected. | Through study completion, an average of 1 year |
| Confirm the false negative rate |
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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.
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
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyun Koo Kim, MD, PhD | Contact | 82-2-2626-3106 | kimhyunkoo@korea.ac.kr | |
| Jiyun Rho, BA | Contact | 82-2-2626-1978 | jiyun.r1219@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hyun Koo Kim, MD, PhD | Korea University Guro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Guro Hospital | Recruiting | Seoul | 08308 | South Korea |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Lung cancer patient
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Carrying out the clinical chemistry examination (Procalcitonin) to check the drug-related safety in 10 lung cancer patients on POD 0 (ng/mL)
| postoperative day 0 |
| Clinical chemistry examination-7 | Carrying out the clinical chemistry examination (Procalcitonin) to check the drug-related safety in 10 lung cancer patients on POD 1 (ng/mL) | postoperative day 1 |
| Clinical chemistry examination-8 | Carrying out the clinical chemistry examination (Procalcitonin) to check the drug-related safety in 10 lung cancer patients on POD 5 (ng/mL) | postoperative day 5 |
| Clinical chemistry examination-9 | 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) | within two weeks before surgery |
| Clinical chemistry examination-10 | 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) | postoperative day 0 |
| Clinical chemistry examination-11 | 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) | postoperative day 1 |
| Clinical chemistry examination-12 | 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) | postoperative day 5 |
| Clinical chemistry examination-13 | 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) | within two weeks before surgery |
| Clinical chemistry examination-14 | 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) | postoperative day 0 |
| Clinical chemistry examination-15 | 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) | postoperative day 1 |
| Clinical chemistry examination-16 | 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) | postoperative day 5 |
| Hematology examination-1 | 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) | within two weeks before surgery |
| Hematology examination-2 | Carrying out the clinical chemistry examination (Mg) to check the drug-related safety in 10 lung cancer patients on POD 0 (mEq/L) | postoperative day 0 |
| Hematology examination-3 | Carrying out the clinical chemistry examination (Mg) to check the drug-related safety in 10 lung cancer patients on POD 1 (mEq/L) | postoperative day 1 |
| Hematology examination-4 | Carrying out the clinical chemistry examination (Mg) to check the drug-related safety in 10 lung cancer patients on POD 5 (mEq/L) | postoperative day 5 |
| Hematology examination-5 | 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) | within two weeks before surgery |
| Hematology examination-6 | Carrying out the clinical hematology examination (hemoglobin, MCHC) to check the drug-related safety in 10 lung cancer patients on POD 0 (g/dL) | postoperative day 0 |
| Hematology examination-7 | Carrying out the clinical hematology examination (hemoglobin, MCHC) to check the drug-related safety in 10 lung cancer patients on POD 1 (g/dL) | postoperative day 1 |
| Hematology examination-8 | Carrying out the clinical hematology examination (hemoglobin, MCHC) to check the drug-related safety in 10 lung cancer patients on POD 5 (g/dL) | postoperative day 5 |
| Hematology examination-9 | 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 (%) | within two weeks before surgery |
| Hematology examination-10 | Carrying out the clinical hematology examination (hematocrit, WBC differential) to check the drug-related safety in 10 lung cancer patients on POD0 (%) | postoperative day 0 |
| Hematology examination-11 | Carrying out the clinical hematology examination (hematocrit, WBC differential) to check the drug-related safety in 10 lung cancer patients on POD1 (%) | postoperative day 1 |
| Hematology examination-12 | Carrying out the clinical hematology examination (hematocrit, WBC differential) to check the drug-related safety in 10 lung cancer patients on POD5 (%) | postoperative day 5 |
| Hematology examination-13 | 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) | within two weeks before surgery |
| Hematology examination-14 | 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) | postoperative day 0 |
| Hematology examination-15 | 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) | postoperative day 1 |
| Hematology examination-16 | 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) | postoperative day 5 |
| Hematology examination-17 | Carrying out the clinical hematology examination (MCV) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery(fL) | within two weeks before surgery |
| Hematology examination-18 | Carrying out the clinical hematology examination (MCV) to check the drug-related safety in 10 lung cancer patients on POD 0 (fL) | postoperative day 0 |
| Hematology examination-19 | Carrying out the clinical hematology examination (MCV) to check the drug-related safety in 10 lung cancer patients on POD 1(fL) | postoperative day 1 |
| Hematology examination-20 | Carrying out the clinical hematology examination (MCV) to check the drug-related safety in 10 lung cancer patients on POD 5 (fL) | postoperative day 5 |
| Hematology examination- 21 | Carrying out the clinical hematology examination (MCH) to check the drug-related safety in 10 lung cancer patients within two weeks before surgery (pg) | within two weeks before surgery |
| Hematology examination- 22 | Carrying out the clinical hematology examination (MCH) to check the drug-related safety in 10 lung cancer patients and POD 0 (pg) | postoperative day 0 |
| Hematology examination- 23 | Carrying out the clinical hematology examination (MCH) to check the drug-related safety in 10 lung cancer patients on POD 1 (pg) | postoperative day 1 |
| Hematology examination- 24 | Carrying out the clinical hematology examination (MCH) to check the drug-related safety in 10 lung cancer patients on POD 5 (pg) | postoperative day 5 |
| Hematology examination- 25 | 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) | within two weeks before surgery |
| Hematology examination- 26 | Carrying out the clinical hematology examination (PT, aPTT) to check the drug-related safety in 10 lung cancer patients on POD 0 (sec) | postoperative day 0 |
| Hematology examination- 27 | Carrying out the clinical hematology examination (PT, aPTT) to check the drug-related safety in 10 lung cancer patients on POD 1 (sec) | postoperative day 1 |
| Hematology examination- 28 | Carrying out the clinical hematology examination (PT, aPTT) to check the drug-related safety in 10 lung cancer patients on POD 5 (sec) | postoperative day 5 |
| Check for changes of urinalysis-1 | Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) within two weeks before surgery (number) | within two weeks before surgery |
| Check for changes of urinalysis-2 | Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) on POD 0 (number) | postoperative day 0 |
| Check for changes of urinalysis-3 | Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) on POD 1(number) | postoperative day 1 |
| Check for changes of urinalysis-4 | Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) on POD 5 (number) | postoperative day 5 |
| Check for changes of urinalysis-5 | 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) | within two weeks before surgery |
| Check for changes of urinalysis-6 | 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) | postoperative day 0 |
| Check for changes of urinalysis-7 | 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) | postoperative day 1 |
| Check for changes of urinalysis-8 | 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) | postoperative day 5 |
| Check for changes of urinalysis-9 | 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 | within two weeks before surgery |
| Check for changes of urinalysis-10 | 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) | postoperative day 0 |
| Check for changes of urinalysis-11 | 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) | postoperative day 1 |
| Check for changes of urinalysis-12 | 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) | postoperative day 5 |
| Observation of the irritable adverse reaction | 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 | Up to 2 hours after drug injection |
| Effective dose measurement | Up to five days after surgery |
Calculation the proportion of cancer cells found in pathological tests among non-sentinel lymph nodes where no fluorescent or nuclear signals were detected. |
| Through study completion, an average of 1 year |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |