Clinical trial NCT05039905: SLN Detection With Tc-MSA-ICG in Lung Cancer Patients
Official title: Development of the Surgical Technique Using Radioactive Fluorescent Dual Contrast Agent for Intraoperative Sentinel Lymph Node Detection in Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Lung Cancer
Keywords: Lung Cancer
Sentinel lymph node
Radioactive fluorescent dual contrast agent
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Lung cancer patient
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical chemistry examination-1 (CRP,Cholesterol,Ca,total,TotalBilirubin,directBilirubin,BUN,Creatinine,Phosphorus, inorganic)
timeFrame: Within two weeks before surgery
measure: Clinical chemistry examination-2
timeFrame: postoperative day 0
measure: Clinical chemistry examination-3
timeFrame: postoperative day 1
measure: Clinical chemistry examination-4
timeFrame: postoperative day 5
measure: Clinical chemistry examination-5
timeFrame: within two weeks before surgery
measure: Clinical chemistry examination-6
timeFrame: postoperative day 0
measure: Clinical chemistry examination-7
timeFrame: postoperative day 1
measure: Clinical chemistry examination-8
timeFrame: postoperative day 5
measure: Clinical chemistry examination-9
timeFrame: within two weeks before surgery
measure: Clinical chemistry examination-10
timeFrame: postoperative day 0
measure: Clinical chemistry examination-11
timeFrame: postoperative day 1
measure: Clinical chemistry examination-12
timeFrame: postoperative day 5
measure: Clinical chemistry examination-13
timeFrame: within two weeks before surgery
measure: Clinical chemistry examination-14
timeFrame: postoperative day 0
measure: Clinical chemistry examination-15
timeFrame: postoperative day 1
measure: Clinical chemistry examination-16
timeFrame: postoperative day 5
measure: Hematology examination-1
timeFrame: within two weeks before surgery
measure: Hematology examination-2
timeFrame: postoperative day 0
measure: Hematology examination-3
timeFrame: postoperative day 1
measure: Hematology examination-4
timeFrame: postoperative day 5
measure: Hematology examination-5
timeFrame: within two weeks before surgery
measure: Hematology examination-6
timeFrame: postoperative day 0
measure: Hematology examination-7
timeFrame: postoperative day 1
measure: Hematology examination-8
timeFrame: postoperative day 5
measure: Hematology examination-9
timeFrame: within two weeks before surgery
measure: Hematology examination-10
timeFrame: postoperative day 0
measure: Hematology examination-11
timeFrame: postoperative day 1
measure: Hematology examination-12
timeFrame: postoperative day 5
measure: Hematology examination-13
timeFrame: within two weeks before surgery
measure: Hematology examination-14
timeFrame: postoperative day 0
measure: Hematology examination-15
timeFrame: postoperative day 1
measure: Hematology examination-16
timeFrame: postoperative day 5
measure: Hematology examination-17
timeFrame: within two weeks before surgery
measure: Hematology examination-18
timeFrame: postoperative day 0
measure: Hematology examination-19
timeFrame: postoperative day 1
measure: Hematology examination-20
timeFrame: postoperative day 5
measure: Hematology examination- 21
timeFrame: within two weeks before surgery
measure: Hematology examination- 22
timeFrame: postoperative day 0
measure: Hematology examination- 23
timeFrame: postoperative day 1
measure: Hematology examination- 24
timeFrame: postoperative day 5
measure: Hematology examination- 25
timeFrame: within two weeks before surgery
measure: Hematology examination- 26
timeFrame: postoperative day 0
measure: Hematology examination- 27
timeFrame: postoperative day 1
measure: Hematology examination- 28
timeFrame: postoperative day 5
measure: Check for changes of urinalysis-1
timeFrame: within two weeks before surgery
measure: Check for changes of urinalysis-2
timeFrame: postoperative day 0
measure: Check for changes of urinalysis-3
timeFrame: postoperative day 1
measure: Check for changes of urinalysis-4
timeFrame: postoperative day 5
measure: Check for changes of urinalysis-5
timeFrame: within two weeks before surgery
measure: Check for changes of urinalysis-6
timeFrame: postoperative day 0
measure: Check for changes of urinalysis-7
timeFrame: postoperative day 1
measure: Check for changes of urinalysis-8
timeFrame: postoperative day 5
measure: Check for changes of urinalysis-9
timeFrame: within two weeks before surgery
measure: Check for changes of urinalysis-10
timeFrame: postoperative day 0
measure: Check for changes of urinalysis-11
timeFrame: postoperative day 1
measure: Check for changes of urinalysis-12
timeFrame: postoperative day 5
measure: Observation of the irritable adverse reaction
timeFrame: Up to 2 hours after drug injection
measure: Effective dose measurement
timeFrame: Up to five days after surgery
Secondary outcomes:
measure: Confirm the sentinel lymph node identification rate
timeFrame: Through study completion, an average of 1 year
measure: Confirm the false negative rate
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Hyun Koo Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: