Small Cell Lung Cancer
Conditions
Brief summary
This prospective observational study aims to evaluate the clinical value of CXCR4-targeted PET/CT imaging in patients with limited-stage small cell lung cancer (LS-SCLC). Patients diagnosed with LS-SCLC at Shandong Cancer Hospital and Institute underwent \[18F\]AlF-NOTA-QHY-04 PET/CT imaging before receiving standard concurrent chemoradiotherapy. Imaging findings were analyzed and correlated with clinical outcomes, including progression-free survival, to explore the potential role of CXCR4 PET/CT as a prognostic imaging biomarker. The results of this study may help improve risk stratification and outcome prediction in patients with limited-stage small cell lung cancer.
Detailed description
This was a single-center, prospective observational study conducted at Shandong Cancer Hospital and Institute to investigate the prognostic value of CXCR4-targeted PET/CT imaging in patients with limited-stage small cell lung cancer (LS-SCLC). Eligible patients with histologically confirmed LS-SCLC underwent \[18F\]AlF-NOTA-QHY-04 PET/CT imaging prior to standard concurrent chemoradiotherapy. PET/CT parameters reflecting CXCR4 expression were measured and analyzed. Patients were subsequently followed up according to routine clinical practice. Clinical outcomes, including progression-free survival and overall survival, were recorded during follow-up. The association between baseline CXCR4 PET/CT imaging findings and clinical outcomes was evaluated to explore the potential role of CXCR4-targeted PET/CT as a prognostic imaging biomarker in LS-SCLC.
Interventions
None listed
Sponsors
Shandong Cancer Hospital and Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histopathologically confirmed limited-stage small cell lung cancer (T1-4N0-3M0) according to the AJCC TNM 8th edition. * Age ≥ 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Presence of measurable disease according to RECIST version 1.1. * Newly diagnosed patients who had not received any prior anticancer treatment. * Underwent baseline \[18F\]AlF-NOTA-QHY-04 PET/CT imaging prior to treatment.
Exclusion criteria
* Presence of autoimmune diseases or active comorbid infections. * Pregnancy or breastfeeding. * Unable or unwilling to provide informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Status at 6 Months After Completion of Concurrent Chemoradiotherapy (CCRT) | 6 months after completion of concurrent chemoradiotherapy (CCRT) | Progression status assessed at 6 months after completion of concurrent chemoradiotherapy (CCRT) using imaging evaluation according to RECIST version 1.1. Participants were classified as having progression (Progressors) or no progression (Non-progressors). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | From date of enrollment until the date of first documented progression (per RECIST version 1.1) or date of death from any cause, whichever came first, assessed up to 36 months | Progression-free survival, defined as the time from study enrollment to disease progression (per RECIST version 1.1) or death from any cause, whichever occurred first. |
Countries
China
Outcome results
None listed