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

NCT05039905 | Unknown Early Phase 1

• 1 other identifier: 2020GR0436
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Lung Cancer; Sentinel lymph node; Radioactive fluorescent dual contrast agent

Outcome Measures

Primary Outcomes (58)

• 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 Outcomes (2)

• Confirm the sentinel lymph node identification rate

  Through study completion, an average of 1 year

• Confirm the false negative rate

  Through study completion, an average of 1 year

Study Arms (1)

99mTc-MSA-ICG injection

EXPERIMENTAL

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

Interventions

99mTc-MSA-ICG DRUG

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

99mTc-MSA-ICG injection

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• 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
• congestive heart failure with symptoms
• New York Heart Association III/IV Class Heart Disease
• Unstable angina
• Symptom or unregulated heart arrhythmia

Sponsors & Collaborators

• Korea University Guro Hospital: lead

Study Sites (1)

Korea University Guro Hospital

Seoul, 08308, South Korea

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hyun Koo Kim, MD, PhD

  Korea University Guro Hospital

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Thoracic and Cardiovascular Surgery

Model Details: Lung cancer patient

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: September 10, 2021
• Study Start: February 15, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: September 10, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)