PET/CTNCT07677787
DLL3-Targeted PET/CT in Small Cell Lung Cancer
A study testing conventional imaging (CT, MRI or 18F-FDG PET/CT), DLL3-targeted PET/CT in people with PET/CT and Small Cell Lung Cancer ( SCLC ), run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
The objective of the study is to evaluate the diagnostic value of DLL3-targeted PET/CT in patients with suspected or histologically confirmed small cell lung cancer, and to compare with conventional imaging modalities. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- PET/CT, Small Cell Lung Cancer ( SCLC ), DLL3-targeted PET/CT
- What is being tested?
- conventional imaging (CT, MRI or 18F-FDG PET/CT), DLL3-targeted PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2026to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (aged 18 years or older);
- Patients with suspected, newly diagnosed, and previously treated small cell lung cancer(supporting evidence may include imaging findings and pathology report);
- Serum ProGRP or NSE level ≥ 3 times the upper limit of normal;
- Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
- Estimated life expectancy of more than 3 months, as assessed by the investigator, and ability to comply with study procedures and scheduled visits;
Who cannot join
- The inability or unwillingness of the research participant or legal representative to provide written informed consent.
- Inability to complete PET/CT imaging.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Haojun Chen contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000
Liang Zhao, 86 18818350620, wzhaoliang01@163.com
About this study
Official title: Delta-like Protein 3 (DLL3)- Targeted PET Imaging in Small Cell Lung Cancer
The objective of the study is to evaluate the diagnostic value of DLL3-targeted PET/CT in patients with suspected or histologically confirmed small cell lung cancer, and to compare with conventional imaging modalities.
Read the detailed description
This study is designed to investigate DLL3-targeted PET/CT as a noninvasive approach for detecting tumor lesions in patients with suspected or confirmed small cell lung cancer (SCLC).In this research, patients with SCLC or highly suspected recurrence detection underwent contemporaneous DLL3-targeted PET/CT and conventional imaging (such as CT, MRI or 18F-FDG) either for an initial assessment or for metastases or highly suspected recurrence detection. Tumor uptake was quantified by the maximum standardized uptake value (SUVmax). By correlating immunohistochemistry with tumor uptake of the DLL3-targeted tracer, the investigators will explore the feasibility of visualizing tumor DLL3 expression using DLL3-targeted PET. The numbers of positive tumor lesions of conventional imaging and DLL3-targeted PET/CT were recorded by visual interpretation. The diagnostic accuracy of DLL3-targeted was calculated and compared to conventional imaging.
- Being tested
- conventional imaging (CT, MRI or 18F-FDG PET/CT), DLL3-targeted PET/CT
- Keywords
- DLL3-targeted PET/CT, PET/CT, Small Cell Lung Cancer, SCLC, Delta-like protein 3
- 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.
conventional imaging (CT, MRI or 18F-FDG PET/CT), DLL3-targeted PET/CTDiagnostic test
Participants will undergo DLL3-Targeted PET/CT imaging for the evaluation of tumor lesions. Imaging findings will be compared with conventional imaging modalities as part of the study analysis.
| Study group | Role | What they receive |
|---|---|---|
| DLL3-targeted PET/CT | Experimental | Each subject receives a single intravenous injection of DLL3-targeted probe and undergoes PET/CT imaging within the specified time. Receives: Diagnostic Test: conventional imaging (CT, MRI or 18F-FDG PET/CT), DLL3-targeted PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinically Significant Abnormal Vital Signs After Administration of the DLL3-targeted Tracer
Vital signs, including body temperature, pulse rate, respiratory rate, systolic blood pressure, and diastolic blood pressure, will be monitored before and after administration of the DLL3-targeted tracer. Participants with at least one clinically significant abnormality in vital signs after tracer administration, as determined by the investigator, will be reported.
Unit of Measure: Participants
Measured: 1 day
Radiation absorbed dose of the DLL3-targeted PET tracer in normal organs and whole body
Radiation dosimetry will be calculated using serial whole-body PET/CT imaging after administration of the DLL3-targeted tracer. Time-activity curves will be generated for major organs, and absorbed doses will be estimated using standard internal dosimetry software (e.g., OLINDA/EXM). Unit of Measure: Absorbed radiation dose (mGy/MBq).
Measured: 1 year
Secondary outcomes (2)
Correlation between tumor DLL3 expression assessed by immunohistochemistry (H-score) and tumor uptake of the DLL3-targeted PET tracer (SUVmax)
Tumor DLL3 expression will be quantified using immunohistochemistry (IHC) and reported as an H-score (range 0-300). Tumor uptake of the DLL3-targeted PET tracer will be measured as maximum standardized uptake value (SUVmax) on PET/CT imaging. The correlation between DLL3 IHC H-score and PET SUVmax will be analyzed to evaluate the feasibility of noninvasively visualizing and quantifying tumor DLL3 expression using DLL3-targeted PET imaging.
Measured: Baseline
Lesion detection rate of 68Ga-DLL3 PET/CT
Measured: The number and proportion of primary and metastatic lesions detected by 68Ga-DLL3 PET/CT compared with conventional imaging modalities (CT, MRI, bone scintigraphy, or 18F-FDG PET/CT, as applicable).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start9 May 2026
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PET/CTStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07677787
- Sponsor's protocol ID
- XMYY-2026KY105
- Status last verified
- May 2026
- First submitted
- 8 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delta-like Protein 3 (DLL3)- Targeted PET Imaging in Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07677787
- Acronym / sponsor ID
- XMYY-2026KY105
- Keywords
- DLL3-targeted PET/CT, PET/CT, Small Cell Lung Cancer, SCLC, Delta-like protein 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 9 May 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 1 Jul 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.
The objective of the study is to evaluate the diagnostic value of DLL3-targeted PET/CT in patients with suspected or histologically confirmed small cell lung cancer, and to compare with conventional imaging modalities.
Detailed description
This study is designed to investigate DLL3-targeted PET/CT as a noninvasive approach for detecting tumor lesions in patients with suspected or confirmed small cell lung cancer (SCLC).In this research, patients with SCLC or highly suspected recurrence detection underwent contemporaneous DLL3-targeted PET/CT and conventional imaging (such as CT, MRI or 18F-FDG) either for an initial assessment or for metastases or highly suspected recurrence detection. Tumor uptake was quantified by the maximum standardized uptake value (SUVmax). By correlating immunohistochemistry with tumor uptake of the DLL3-targeted tracer, the investigators will explore the feasibility of visualizing tumor DLL3 expression using DLL3-targeted PET. The numbers of positive tumor lesions of conventional imaging and DLL3-targeted PET/CT were recorded by visual interpretation. The diagnostic accuracy of DLL3-targeted was calculated and compared to conventional imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DLL3-targeted PET/CT | Experimental | Diagnostic Test: conventional imaging (CT, MRI or 18F-FDG PET/CT), DLL3-targeted PET/CTEach subject receives a single intravenous injection of DLL3-targeted probe and undergoes PET/CT imaging within the specified time. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (aged 18 years or older);
- Patients with suspected, newly diagnosed, and previously treated small cell lung cancer(supporting evidence may include imaging findings and pathology report);
- Serum ProGRP or NSE level ≥ 3 times the upper limit of normal;
- Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
- Estimated life expectancy of more than 3 months, as assessed by the investigator, and ability to comply with study procedures and scheduled visits;
Key exclusion criteria (2 listed)
- The inability or unwillingness of the research participant or legal representative to provide written informed consent.
- Inability to complete PET/CT imaging.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional imaging (CT, MRI or 18F-FDG PET/CT), DLL3-targeted PET/CTParticipants will undergo DLL3-Targeted PET/CT imaging for the evaluation of tumor lesions. Imaging findings will be compared with conventional imaging modalities as part of the study analysis. | Diagnostic test | DLL3-targeted PET/CT |
Primary outcome
Number of Participants With Clinically Significant Abnormal Vital Signs After Administration of the DLL3-targeted Tracer
Time frame: 1 day
Vital signs, including body temperature, pulse rate, respiratory rate, systolic blood pressure, and diastolic blood pressure, will be monitored before and after administration of the DLL3-targeted tracer. Participants with at least one clinically significant abnormality in vital signs after tracer administration, as determined by the investigator, will be reported. Unit of Measure: Participants
Radiation absorbed dose of the DLL3-targeted PET tracer in normal organs and whole body
Time frame: 1 year
Radiation dosimetry will be calculated using serial whole-body PET/CT imaging after administration of the DLL3-targeted tracer. Time-activity curves will be generated for major organs, and absorbed doses will be estimated using standard internal dosimetry software (e.g., OLINDA/EXM). Unit of Measure: Absorbed radiation dose (mGy/MBq).
2 secondary outcomes
Correlation between tumor DLL3 expression assessed by immunohistochemistry (H-score) and tumor uptake of the DLL3-targeted PET tracer (SUVmax)
Time frame: Baseline
Lesion detection rate of 68Ga-DLL3 PET/CT
Time frame: The number and proportion of primary and metastatic lesions detected by 68Ga-DLL3 PET/CT compared with conventional imaging modalities (CT, MRI, bone scintigraphy, or 18F-FDG PET/CT, as applicable).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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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.
Haojun Chen contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional imaging (CT, MRI or 18F-FDG PET/CT), DLL3-targeted PET/CT in people with PET/CT and Small Cell Lung Cancer ( SCLC ), run by The First Affiliated Hospital of Xiamen University 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 1 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liang Zhao (86 18818350620, wzhaoliang01@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Clinically Significant Abnormal Vital Signs After Administration of the DLL3-targeted Tracer (time frame: 1 day). The study lists 2 primary outcomes in all. 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 1 Jul 2026.