NCT07458906

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress40%
Dec 2025Dec 2026

Study Start

First participant enrolled

December 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 9, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 9, 2026

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

January 18, 2026

Last Update Submit

March 4, 2026

Conditions

DLL3-expressing TumorsPET / CTNeuroendocrine Cancer

Keywords

DLL3-expressing tumorsPET/CTNeuroendocrine Cancer

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    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)

    1 year

Other Outcomes (1)

  • Intertumoral heterogeneity

    1 year

Study Arms (1)

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.

Diagnostic Test: Diagnostic Test: conventional imaging (CT, MRI or 18F-FDG PET/CT), DLL3-targeted PET/CT

Interventions

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.

DLL3-targeted PET/CT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • The inability or unwillingness of the research participant or legal representative to provide written informed consent.
  • Inability to complete PET/CT imaging.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Neuroendocrine

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Liang Zhao

CONTACT

86 18818350620wzhaoliang01@163.com

Haojun Chen

CONTACT

86 18659285282leochen0821@foxmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2026

First Posted

March 9, 2026

Study Start

December 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 9, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)