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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05039905
• Other study ID #: 2020GR0436
• Status: Recruiting
• Phase: Early Phase 1
• Start date: February 15, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: September 2021
• Source: Korea University Guro Hospital
• Contact: Hyun Koo Kim, MD, PhD
• Phone: 82-2-2626-3106
• Email: kimhyunkoo[@]korea.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• 99mTc-MSA-ICG
Intratumoral injection of 99mTechnetium-manosylated albumin-indocyanine green to lung cancer patients

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Guro Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Effective dose measurement		Up to five days after surgery
Secondary	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
Secondary	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