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

NCT ID: NCT07316309

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

33 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-28

Study Completion Date

2025-09-02

Brief Summary

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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

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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.

Conditions

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Small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong Cancer Hospital and Institute

OTHER

Sponsor Role lead

Responsible Party

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Jie Liu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jie Liu

Role: PRINCIPAL_INVESTIGATOR

Shandong Cancer Hospital and Institute

Locations

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Shandong Cancer Hospital and Institute

Jinan, Shandong, China

Site Status

Countries

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China

Other Identifiers

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QHY04-LS-SCLC-01

Identifier Type: -

Identifier Source: org_study_id

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