CXCR4 PET/CT for Predicting Outcome in Limited-Stage Small Cell Lung Cancer

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.

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Key information

Conditions

Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shandong Cancer Hospital and Institute

Jinan, Shandong, 250117, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Progression Status at 6 Months After Completion of Concurrent Chemoradiotherapy (CCRT)

Time frame: 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 outcomes

Progression-Free Survival (PFS)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shandong Cancer Hospital and Institute

Other

Registry information

Official study title

A Prospective Study of [18F]AlF-NOTA-QHY-04 PET/CT for Predicting Outcome in Patients With Limited-Stage Small Cell Lung Cancer Treated With Concurrent Chemoradiotherapy

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2025
First posted: Jan 5, 2026
Registry last updated: Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed