Small Cell Lung CancerNCT07316309
CXCR4 PET/CT for Predicting Outcome in Limited-Stage Small Cell Lung Cancer
An observational study of Small Cell Lung Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 28 Nov 2022to 2 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Presence of autoimmune diseases or active comorbid infections.
- Pregnancy or breastfeeding.
- Unable or unwilling to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Small Cell Lung Cancer
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months after completion of concurrent chemoradiotherapy (CCRT)
Secondary outcomes (1)
Progression-Free Survival (PFS)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start28 Nov 2022
- Primary completion19 Jul 2024
- Study completion2 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Liu, Shandong Cancer Hospital and Institute
- Investigators
- Jie Liu, Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316309
- Sponsor's protocol ID
- QHY04-LS-SCLC-01
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07316309
- Acronym / sponsor ID
- QHY04-LS-SCLC-01
- Conditions
- Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 19 Jul 2024 (actual)
- Study completion
- 2 Sep 2025 (actual)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Presence of autoimmune diseases or active comorbid infections.
- Pregnancy or breastfeeding.
- Unable or unwilling to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Liu principal investigator
Shandong Cancer Hospital and Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Cell Lung Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Status at 6 Months After Completion of Concurrent Chemoradiotherapy (CCRT) (time frame: 6 months after completion of concurrent chemoradiotherapy (CCRT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.