Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-25 @ 3:33 AM
NCT ID:
NCT05039905
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT05039905
Study Brief:
Protocol Section:
NCT05039905