MedPath

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

Early Phase 1
Conditions
Lung Cancer
Interventions
Drug: 99mTc-MSA-ICG
Registration Number
NCT05039905
Lead Sponsor
Korea University Guro Hospital
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
10
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
Read More
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

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
99mTc-MSA-ICG injection99mTc-MSA-ICG99mTc-MSA-ICG injection 1mCi of 99mTc 1mg of MSA 0.1mg of ICG Total 1cc injection volume at 2 hours before the surgery
Primary Outcome Measures
NameTimeMethod
Clinical chemistry examination-4postoperative 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)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-2postoperative 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-5within 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-6postoperative 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-12postoperative 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-13within 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-14postoperative 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-5within 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-7postoperative 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-9within 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-10postoperative 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-11postoperative 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-13within 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-20postoperative 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-3postoperative 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-8postoperative 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-9within 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-10postoperative 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-15postoperative 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-2postoperative 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-3postoperative 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-4postoperative 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-12postoperative 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-14postoperative 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- 21within 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- 22postoperative 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-7postoperative 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-11postoperative 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-16postoperative 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-1within 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-6postoperative 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-8postoperative 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-18postoperative 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- 24postoperative 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- 28postoperative 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 measurementUp to five days after surgery
Hematology examination-15postoperative 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-16postoperative 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-17within 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-19postoperative 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- 27postoperative 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- 23postoperative 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-3postoperative day 1

Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) on POD 1(number)

Check for changes of urinalysis-4postoperative day 5

Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) on POD 5 (number)

Check for changes of urinalysis-7postoperative 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- 25within 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- 26postoperative 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-1within 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-2postoperative day 0

Carrying out the urinalysis examination(specific gravity, pH, glucose, bilirubin in urine) on POD 0 (number)

Check for changes of urinalysis-5within 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-6postoperative 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-8postoperative 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-9within 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-10postoperative 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-11postoperative 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-12postoperative 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 reactionUp 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 Outcome Measures
NameTimeMethod
Confirm the false negative rateThrough 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 rateThrough 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.

Trial Locations

Locations (1)

Korea University Guro Hospital

🇰🇷

Seoul, Korea, Republic of

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy