DLL3-expressing TumorsNCT07458906
DLL3-Targeted PET/CT in Neuroendocrine Carcinoma
A study testing Diagnostic Test: conventional imaging (CT, MRI or 18F-FDG PET/CT), DLL3-targeted PET/CT in people with DLL3-expressing Tumors and PET / CT, 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 neuroendocrine carcinoma, 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
- DLL3-expressing Tumors, PET / CT, Neuroendocrine Cancer
- What is being tested?
- Diagnostic Test: 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
- 80 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2026to 31 Dec 2026
- 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 neuroendocrine carcinoma(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.
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 Neuroendocrine Carcinoma
The objective of the study is to evaluate the diagnostic value of DLL3-targeted PET/CT in patients with suspected or histologically confirmed neuroendocrine carcinoma, 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 neuroendocrine carcinoma.
In this research, patients with neuroendocrine carcinoma 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. Intertumoral heterogeneity was assessed using the coefficient of variation (CV) of SUVmax across all lesions within each patient.
- Conditions
- DLL3-expressing Tumors, PET / CT, Neuroendocrine Cancer
- Being tested
- Diagnostic Test: conventional imaging (CT, MRI or 18F-FDG PET/CT), DLL3-targeted PET/CT
- Keywords
- DLL3-expressing tumors, PET/CT, Neuroendocrine Cancer
- Medical subject headings
- Carcinoma, Neuroendocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic Test: 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: 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.
Changes in vital signs after administration of the DLL3-targeted tracer
Vital signs will be monitored before and after administration of the DLL3-targeted tracer, including body temperature, pulse rate, respiratory rate, and blood pressure. Units of Measure: Body temperature (°C); Pulse rate (beats/min); Respiratory rate (breaths/min); Blood pressure (mmHg).
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 (1)
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: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start10 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DLL3-expressing TumorsStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458906
- Sponsor's protocol ID
- XMYY-2025KY280
- Status last verified
- Dec 2025
- First submitted
- 18 Jan 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 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 Neuroendocrine Carcinoma
- ClinicalTrials.gov ID
- NCT07458906
- Acronym / sponsor ID
- XMYY-2025KY280
- Conditions
- DLL3-expressing Tumors, PET / CT, Neuroendocrine Cancer
- Keywords
- DLL3-expressing tumors, PET/CT, Neuroendocrine Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Mar 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 neuroendocrine carcinoma, 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 neuroendocrine carcinoma.
In this research, patients with neuroendocrine carcinoma 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. Intertumoral heterogeneity was assessed using the coefficient of variation (CV) of SUVmax across all lesions within each patient.
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: 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 neuroendocrine carcinoma(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 |
|---|---|---|
| Diagnostic Test: 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
Changes in vital signs after administration of the DLL3-targeted tracer
Time frame: 1 day
Vital signs will be monitored before and after administration of the DLL3-targeted tracer, including body temperature, pulse rate, respiratory rate, and blood pressure. Units of Measure: Body temperature (°C); Pulse rate (beats/min); Respiratory rate (breaths/min); Blood pressure (mmHg).
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).
1 secondary outcome
Correlation between tumor DLL3 expression assessed by immunohistochemistry (H-score) and tumor uptake of the DLL3-targeted PET tracer (SUVmax)
Time frame: 1 year
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 25 Sep 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic Test: conventional imaging (CT, MRI or 18F-FDG PET/CT), DLL3-targeted PET/CT in people with DLL3-expressing Tumors and PET / CT, 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 25 Sep 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?
Changes in 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 25 Sep 2026.