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

Early Phase 1UnknownNCT05039905

Korea University Guro Hospital10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Lung Cancer

Interventions

99mTc-MSA-ICGDRUG

Intratumoral injection of 99mTechnetium-manosylated albumin-indocyanine green to lung cancer patients

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: Within two weeks before surgery

Clinical chemistry examination-2

Time frame: postoperative day 0

Clinical chemistry examination-3

Time frame: postoperative day 1

Clinical chemistry examination-4

Time frame: 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)

Time frame: within two weeks before surgery

Clinical chemistry examination-6

Carrying out the clinical chemistry examination (Procalcitonin) to check the drug-related safety in 10 lung cancer patients on POD 0 (ng/mL)

Central Contacts

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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 (%)

Time frame: 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 (%)

Time frame: 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 (%)

Time frame: 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 (%)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: Up to 2 hours after drug injection

Effective dose measurement

Time frame: Up to five days after surgery

Secondary Outcomes

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.

Time frame: Through study completion, an average of 1 year

Confirm the false negative rate

Calculation the proportion of cancer cells found in pathological tests among non-sentinel lymph nodes where no fluorescent or nuclear signals were detected.

Time frame: Through study completion, an average of 1 year