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Comparing DLL3 PET/CT to Standard Scans in Neuroendocrine Cancer

NCT07733024 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-07-29

No results posted yet for this study

Summary

This study is testing a new PET/CT scan that uses a special tracer called \[⁶⁸Ga\]Ga-DLL3 nanobody to see if it can better detect cancer spread (metastases) in people with neuroendocrine tumors than the standard scans currently used (FDG PET/CT or PSMA PET/CT). DLL3 is a protein found on the surface of many neuroendocrine tumor cells, and the new tracer is designed to stick to this protein, making tumors visible on the scan. The goal is to find out whether this new imaging method can give doctors more accurate information about where the cancer has spread and help them choose the most appropriate treatment for each patient.

The study is prospective, multi-center, and self-controlled, meaning each participant will receive both the new scan and the standard scan, allowing a direct side-by-side comparison in the same person. Depending on the type of neuroendocrine tumor, participants will be assigned to one of two groups: one group will be compared with FDG PET/CT and the other with PSMA PET/CT. The two scans will be performed within two weeks of each other, and all images will be read by independent experts who do not know the patient's clinical history, to ensure objective and unbiased results.

The investigators plan to enroll about 180-200 patients aged 18 or older who have confirmed neuroendocrine tumors with at least two metastatic sites. The total duration of participation is approximately 6 months, consisting of a screening period of up to 14 days, two imaging scans completed within 2 days, and a final follow-up visit at 6 months to evaluate participants' health and disease progression. Participation is entirely voluntary, and participants may withdraw at any time without affecting participants' standard medical care.

Conditions

Interventions

DRUG

68Ga-PFD3

\[⁶⁸Ga\]Ga-PFD3 is a novel PET tracer constructed by conjugating a DLL3-specific nanobody (single-domain antibody, \~15 kDa) with a chelator for ⁶⁸Ga radiolabeling. DLL3 (Delta-like ligand 3) is a cell-surface protein that is rarely expressed in healthy adult tissues but is overexpressed in over 80% of small cell lung cancer and in other high-grade neuroendocrine tumors, making it an attractive target for molecular imaging. The nanobody platform offers advantages over conventional monoclonal antibody-based tracers (e.g., \[⁸⁹Zr\]Zr-DFO-SC16.56): smaller size (\~15 kDa vs. \~150 kDa) enables superior tissue penetration, rapid blood clearance, and shorter in vivo residence time, allowing same-day PET/CT imaging within hours post-injection. Participants receive a single intravenous injection of \[⁶⁸Ga\]Ga-PFD3 (activity: 111-185 MBq; protein mass and molar activity controlled per protocol), followed by whole-body PET/CT acquisition at approximately 2 hours post-injection. Images are acquired from

Sponsors & Collaborators

  • Tingting Yuan

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-06
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07733024 on ClinicalTrials.gov