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

Development of the Surgical Technique Using Radioactive Fluorescent Dual Contrast Agent for Intraoperative Sentinel Lymph Node Detection in Lung Cancer Patients

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: 99mTc-MSA-ICG

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Hyun Koo Kim, MD, PhD; Phone Number: 82-2-2626-3106; Email: kimhyunkoo@korea.ac.kr
• Study Contact Backup: Name: Jiyun Rho, BA; Phone Number: 82-2-2626-1978; Email: jiyun.r1219@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 08308
    • Recruiting
    • Korea University Guro Hospital
    • Contact: Jiyun Rho, BA; Phone Number: 82-2-2626-1978; Email: jiyun.r1219@gmail.com
    • Contact: Seunghoe Song, MBE; Phone Number: 82-2-2626-1635; Email: ssessong@korea.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: 99mTc-MSA-ICG; Intratumoral injection of 99mTechnetium-manosylated albumin-indocyanine green to lung cancer patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Korea University Guro Hospital
• Investigators: Principal Investigator: Hyun Koo Kim, MD, PhD, Korea University Guro Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 10, 2021

Study Record Updates

• Last Update Posted (Actual): September 10, 2021
• Last Update Submitted That Met QC Criteria: September 9, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Lung Cancer; Sentinel lymph node; Radioactive fluorescent dual contrast agent
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2020GR0436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No