Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
10 participants
INTERVENTIONAL
2021-02-15
2021-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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
99mTc-MSA-ICG
Intratumoral injection of 99mTechnetium-manosylated albumin-indocyanine green to lung cancer patients
Interventions
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99mTc-MSA-ICG
Intratumoral injection of 99mTechnetium-manosylated albumin-indocyanine green to lung cancer patients
Eligibility Criteria
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Exclusion Criteria
* 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
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
20 Years
ALL
No
Sponsors
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Korea University Guro Hospital
OTHER
Responsible Party
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Hyun Koo Kim
Professor of Thoracic and Cardiovascular Surgery
Principal Investigators
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Hyun Koo Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Korea University Guro Hospital
Locations
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Korea University Guro Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020GR0436
Identifier Type: -
Identifier Source: org_study_id
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