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

NCT ID: NCT05039905

Last Updated: 2021-09-10

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2021-12-31

Brief Summary

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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

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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

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Lung cancer patient
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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

Group Type EXPERIMENTAL

99mTc-MSA-ICG

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* 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

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea University Guro Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyun Koo Kim

Professor of Thoracic and Cardiovascular Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyun Koo Kim, MD, PhD

Role: CONTACT

82-2-2626-3106

Jiyun Rho, BA

Role: CONTACT

82-2-2626-1978

Facility Contacts

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Jiyun Rho, BA

Role: primary

82-2-2626-1978

Seunghoe Song, MBE

Role: backup

82-2-2626-1635

Other Identifiers

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2020GR0436

Identifier Type: -

Identifier Source: org_study_id

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