Comparing DLL3 PET/CT to Standard Scans in Neuroendocrine Cancer

Sponsor
Tingting Yuan
Study ID
NCT07733024
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 68Ga-PFD3 — DRUG
    \[⁶⁸Ga\]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

Study Details

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.

Key Dates

First listed
Jul 29, 2026
Start date
Jul 6, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: [⁶⁸Ga]Ga-DLL3 Nanobody PET/CT
    Participants receive a single intravenous injection of \[⁶⁸Ga\]Ga-DLL3 nanobody (a novel radiotracer targeting Delta-like ligand 3 \[DLL3\]), followed by whole-body PET/CT imaging at approximately 2 hours post-injection. DLL3 is a protein aberrantly expressed on the surface of neuroendocrine tumor cells. The nanobody is engineered for high-affinity and specificity binding to DLL3, enabling non-invasive visualization of DLL3-expressing tumor lesions. The total injected protein mass and molar activity are controlled according to the study protocol to ensure consistent imaging quality. PET/CT images are acquired from skull base to mid-thigh (extended to feet if clinically indicated) using a standardized acquisition protocol. Image reconstruction is performed with consistent algorithms across all participants. Each subject serves as their own control, with the DLL3 PET/CT results compared to their conventional imaging (FDG PET/CT or PSMA PET/CT) performed within 2 weeks. The scan is performed

Primary Outcome Measure

Diagnostic Accuracy of [⁶⁸Ga]Ga-DLL3 Nanobody PET/CT in Detecting Metastatic Lesions [ Time Frame: Baseline (within 14 days of enrollment) and Month 6 ]

Central Contacts

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