Lung Cancer
Conditions
Keywords
Lung Cancer, Sentinel lymph node, Radioactive fluorescent dual contrast agent
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.
Interventions
DRUG99mTc-MSA-ICG
Intratumoral injection of 99mTechnetium-manosylated albumin-indocyanine green to lung cancer patients
Sponsors
Korea University Guro Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Lung cancer patient
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effective dose measurement | Up to five days after surgery | — |
| Check for changes of urinalysis-12 | 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 | 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 |
| Clinical chemistry examination-1 (CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic) | 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 | 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-3 | 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-4 | 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-5 | 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 | 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-7 | 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-8 | 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 | 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 | 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-11 | 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-12 | 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 | 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 | 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) |
| Clinical chemistry examination-15 | 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) |
| Clinical chemistry examination-16 | 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 | 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-2 | 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 | 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 | 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-5 | 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-6 | 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-7 | 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-8 | 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-9 | 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 | 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 | 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-12 | 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-13 | 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-14 | 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-15 | 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 | 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 | 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) |
| Check for changes of urinalysis-7 | 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) |
| Check for changes of urinalysis-8 | 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) |
| Hematology examination-18 | 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-19 | 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-20 | 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) |
| Hematology examination- 21 | 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 | 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) |
| Hematology examination- 23 | 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) |
| Hematology examination- 24 | 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- 25 | 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 | 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) |
| Hematology examination- 27 | 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- 28 | 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) |
| Check for changes of urinalysis-1 | 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 | postoperative day 0 | Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) on POD 0 (number) |
| Check for changes of urinalysis-3 | 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 | postoperative day 5 | Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) on POD 5 (number) |
| Check for changes of urinalysis-5 | 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 | 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-9 | 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 | 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 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Confirm the false negative rate | Through study completion, an average of 1 year | Calculation the proportion of cancer cells found in pathological tests among non-sentinel lymph nodes where no fluorescent or nuclear signals were detected. |
| Confirm the sentinel lymph node identification rate | Through study completion, an average of 1 year | Calculation the percentage of cancer cells found in pathological test among sentinel lymph nodes where fluorescent or nuclear signal are detected. |
Countries
South Korea
Contacts
Primary ContactHyun Koo Kim, MD, PhD
Backup ContactJiyun Rho, BA
Outcome results
None listed