Status unknownNCT05039905Updated Sep 10, 2021

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

An Early Phase 1 interventional study of 99mTc-MSA-ICG in Lung Cancer, sponsored by Korea University Guro Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-09-10.

Sponsored by Korea University Guro Hospital · Early Phase 1, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Sep 2021), so the status shown — last known as Recruiting — may be out of date.

Phase: Early Phase 1
Study type: Interventional
Enrollment: 10
Allocation: Not applicable
Ages: 20 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Lung Cancer

Browse trials for

Lung Neoplasms 7,243

Keywords

Lung Cancer
Sentinel lymph node
Radioactive fluorescent dual contrast agent

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 10 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Korea University Guro Hospital is the lead sponsor of 83 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Early Phase 1
Primary purpose: Diagnostic
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 10 participants (estimated)

Study arms

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

Interventions

Drug99mTc-MSA-ICG
Intratumoral injection of 99mTechnetium-manosylated albumin-indocyanine green to lung cancer patients

What researchers measure

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
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)
Time frame: 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)
Time frame: 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)
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)
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

Study locations

1 of 1 sites recruiting

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05039905
Lead sponsor: Korea University Guro Hospital
Responsible party: Hyun Koo Kim (Professor of Thoracic and Cardiovascular Surgery, Korea University Guro Hospital) — Principal investigator
First posted: Sep 10, 2021
Start date: Feb 15, 2021
Primary completion: Dec 31, 2021 (estimated)
Completion: Dec 31, 2021 (estimated)
Last update: Sep 10, 2021

Study contacts

Hyun Koo Kim, MD, PhD

Contact

kimhyunkoo@korea.ac.kr

82-2-2626-3106

Jiyun Rho, BA

Contact

jiyun.r1219@gmail.com

82-2-2626-1978

Hyun Koo Kim, MD, PhD

principal investigator · Korea University Guro Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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