Using imaging biomarkers to assess treatment response in lung cancer patients
Imaging Biomarkers for Immune Checkpoint Inhibitor Treatment in Patients With Non-small Cell Lung Cancer: Prospective Observational Study
Samsung Medical Center · NCT05260606
This study is testing if special imaging can help predict how well lung cancer patients respond to new immune treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center (other) |
| Drugs / interventions | nivolumab, pembrolizumab, atezolizumab, chemotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05260606 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the relationship between metabolic imaging parameters obtained from F-18 fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) and clinical outcomes in patients with non-small cell lung cancer (NSCLC) undergoing treatment with immune checkpoint inhibitors (ICIs). The study will involve patients aged 18 and older with pathologically confirmed NSCLC, focusing on how imaging can predict treatment response and patient prognosis. By utilizing a prospective observational design, the study seeks to provide insights into the effectiveness of FDG PET/CT as a predictive tool for therapeutic response in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with pathologically confirmed non-small cell lung cancer who are set to receive immune checkpoint inhibitors.
Not a fit: Patients without measurable lesions or those with significant uncontrolled health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict treatment responses in lung cancer patients, leading to more personalized and effective treatment strategies.
How similar studies have performed: While there have been retrospective studies suggesting the potential of FDG PET/CT in this context, this prospective approach is relatively novel and aims to provide more definitive insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18 years old or over 2. pathologically proven non-small cell lung cancer: adenocarcinoma or squamous cell carcinoma 3. patients to be treated with immune checkpoint inhibitors (nivolumab or pembrolizumab or atezolizumab) 4. ECOG performance status ≤ 2 5. A person who have heard the detailed explanation of this clinical trial and are willing to voluntarily decide to participate and sign the informed consent form Exclusion Criteria: 1. subjects without measurable lesion: They must have at least one measurable lesion with a diameter of 10 mm by spiral CT or multi-detector CT (MD CT) or 20 mm or larger by conventional CT. 2. subjects with a history of other malignant diseases within the past 5 years, except for treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, cured thyroid cancer, and early gastric cancer 3. subjects with clinically significant uncontrolled seizures, central nervous system disease, or psychiatric disorders that, in the investigator's judgment, interferes with or is likely to interfere with the understanding of informed consent 4. subjects with uncontrolled diabetes 5. subjects with severe uncontrolled infection 6. subjects who underwent major surgery within 4 weeks prior to the start of the clinical trial or who have not fully recovered from the effects of major surgery 7. pregnant or lactating patients 8. subjects who have not received a pregnancy test or have a positive result during the basic test (menopause women with amenorrhea period of at least 12 months or longer are considered infertile subjects) 9. women or men of childbearing potential who are unwilling to use contraception during the clinical trial period
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, Korea, Republic of (RECRUITING)
Study contacts
- Principal investigator: hoyun lee, M.D., Ph.D. — Samsung Medical Center, Department radiology
- Study coordinator: Seung hwan Moon, M.D., Ph.D.
- Email: seunghwan.moons.moon@samsung.com
- Phone: +82-2-3410-6293
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Carcinoma, Non-Small-Cell Lung, Immune Checkpoint Inhibitors