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

NCT07316309 | Completed

• 1 other identifier: QHY04-LS-SCLC-01
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Status at 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).

  6 months after completion of concurrent chemoradiotherapy (CCRT)

Secondary Outcomes (1)

• 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

Study Arms (1)

Limited-Stage Small Cell Lung Cancer Cohort

Patients with histologically confirmed limited-stage small cell lung cancer who were enrolled prospectively and received standard-of-care treatment according to institutional protocols.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with newly diagnosed, histopathologically confirmed limited-stage small cell lung cancer who underwent baseline \[18F\]AlF-NOTA-QHY-04 PET/CT imaging prior to concurrent chemoradiotherapy at Shandong Cancer Hospital and Institute.

You may qualify if:

• 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.

You may not qualify if:

• Presence of autoimmune diseases or active comorbid infections.
• Pregnancy or breastfeeding.
• Unable or unwilling to provide informed consent.

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Shandong Cancer Hospital and Institute

Jinan, Shandong, 250117, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jie Liu

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 5, 2026
• Study Start: November 28, 2022
• Primary Completion: July 19, 2024
• Study Completion: September 2, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)