68Ga-PFD3 PET Imaging for the Diagnosis and Evaluation of Small Cell Lung Cancer
Targeting Delta-like Ligand 3 (DLL3) With 68Ga-PFD3 PET/CT for the Diagnosis and Assessment of Small Cell Lung Cancer (SCLC)
1 other identifier
interventional
30
1 country
1
Brief Summary
This study aims to investigate and evaluate the safety and performance of a novel probe, PFD3, for the diagnosis and assessment of patients with small cell lung cancer (SCLC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2025
Typical duration for phase_1
1 active site
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 Start
First participant enrolled
October 22, 2025
CompletedFirst Submitted
Initial submission to the registry
March 21, 2026
CompletedFirst Posted
Study publicly available on registry
April 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
June 18, 2026
June 1, 2026
1.2 years
March 21, 2026
June 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adverse events (assessed using CTCAE grades)
Post-injection, patients will be assessed for treatment-related adverse events at 24 hours and within one week, using CTCAE grades. The \[68Ga\]Ga-PFD3 PET/CT will be considered safe if no possible or confirmed, Grade 3 or higher adverse events are identified.
1 week after injection
Correlation between PFD3 uptake and DLL3 expression
Quantitative assessment of DLL3 expression in patient biopsy lesions using immunohistochemistry will be correlated with uptake parameters from \[68Ga\]Ga-PFD3 PET/CT scans.
Baseline
Secondary Outcomes (3)
Imaging performance of [68Ga]Ga-PFD3 PET/CT
Baseline
Progression-free survival
From baseline PET/CT imaging to disease progression or death, assessed up to 12 months post-imaging
Overall Survival
Through study completion, an average of 13 months
Study Arms (1)
Eligible participants
EXPERIMENTALSequential \[18F\]-FDG PET/CT and \[68Ga\]Ga-PFD3 PET/CT
Interventions
Based on individual clinical circumstances, eligible patients will undergo sequential \[18F\]FDG PET/CT and \[68Ga\]Ga-PFD3 PET/CT scans within one week.
Based on individual clinical circumstances, eligible patients will undergo sequential \[18F\]FDG PET/CT and \[68Ga\]Ga-PFD3 PET/CT scans within one week.
Eligibility Criteria
You may qualify if:
- Adults.
- Histologically confirmed small cell lung cancer (SCLC).
- At least one measurable lesion ≥1 cm in diameter (primary tumor, metastatic lesion, or involved lymph node) confirmed by standard imaging modalities.
- Laboratory tests (complete blood count and biochemical analysis) completed within 4 weeks prior to enrollment.
You may not qualify if:
- Pregnancy.
- Breastfeeding.
- Acute psychiatric disorders.
- Inability to undergo PET scanning (e.g., due to claustrophobia, weight limits, or other medical contraindications).
- Inability to complete the study procedures as anticipated.
- Prior therapy targeting DLL3.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking university first hospital nuclear medicine
Beijing, Beijing Municipality, 100034, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending physician
Study Record Dates
First Submitted
March 21, 2026
First Posted
April 2, 2026
Study Start
October 22, 2025
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
June 18, 2026
Record last verified: 2026-06