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Clinical Trials in China / NCT07508852
Recruiting Phase 1/2

68Ga-PFD3 PET Imaging for the Diagnosis and Evaluation of Small Cell Lung Cancer

NCT07508852 · tracked via the Priya Life Science China tracker
Sponsor
Peking University First Hospital
Phase
Phase 1/2
Started
2025-10-22
Last updated
2026-06-18

Condition(s) studied

SCLCSCLC, Extensive StageSCLC, Limited StageSmall Cell Lung CancerSmall Cell Lung Cancer ( SCLC )

Investigational drug(s) / intervention(s)

Sequential [18F]-FDG PET/CT[68Ga]Ga-PFD3 PET/CT scan

Sequential [18F]-FDG PET/CT: Based on individual clinical circumstances, eligible patients will undergo sequential \[18F\]FDG PET/CT and \[68Ga\]Ga-PFD3 PET/CT scans within one week.

[68Ga]Ga-PFD3 PET/CT scan: Based on individual clinical circumstances, eligible patients will undergo sequential \[18F\]FDG PET/CT and \[68Ga\]Ga-PFD3 PET/CT scans within one week.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Adverse events (assessed using CTCAE grades) — 1 week after injection
    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.
  • Correlation between PFD3 uptake and DLL3 expression — Baseline
    Quantitative assessment of DLL3 expression in patient biopsy lesions using immunohistochemistry will be correlated with uptake parameters from \[68Ga\]Ga-PFD3 PET/CT scans.

Trial sites (1)

FacilityCityRegionStatus
Peking university first hospital nuclear medicine Beijing Beijing Municipality Recruiting

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Other trials for the same condition

A Phase I Study to Evaluate the Safety and Preliminary Efficacy of [225Ac]Ac-DOTATATE Injection Combined With Tislelizumab in the Maintenance Treatment Period for Patients of Extensive-stage Small Cell Lung Cancer (ES-SCLC) With Somatostatin Receptors (SSTR)+ as First-line Treatment Recruiting
Placebo-controlled, Study of Concurrent Chemoradiation Therapy With Pembrolizumab Followed by Pembrolizumab and Olaparib in Newly Diagnosed Treatment-Naïve Limited-Stage Small Cell Lung Cancer (LS-SCLC) (MK 7339-013/KEYLYNK-013) Active, not recruiting
A Study of PM8002 in Combination With Chemotherapy in Patients With SCLC Active, not recruiting
A Study of DXC006 With Immune Checkpoint Inhibitors or Platinum for Small Cell Lung Cancer. Recruiting
A Study of AK112 as Consolidation Treatment for Patients With Limited Stage Small-cell Lung Cancer Who Have Not Progressed Following Concurrent Chemoradiation Therapy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07508852 on ClinicalTrials.gov ↗ ← All trials in China