Using a new PFD3 PET tracer to find and stage 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)
PHASE1; PHASE2 · Peking University First Hospital · NCT07508852
This test will try a new PET tracer called PFD3 in adults with small cell lung cancer to see if it detects tumors and stages disease more accurately than standard FDG PET/CT.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peking University First Hospital (other) |
| Drugs / interventions | rovalpituzumab, chemotherapy, radiation |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07508852 on ClinicalTrials.gov |
What this trial studies
This phase 1/2 interventional study gives enrolled adults with histologically confirmed SCLC sequential PET/CT scans using standard [18F]-FDG and the investigational [68Ga]-PFD3 tracer to compare imaging performance and safety. The protocol focuses on patients with at least one measurable lesion and includes laboratory monitoring and imaging-based endpoints. Primary goals include characterizing PFD3 safety and measuring how well it identifies tumor sites and distinguishes limited- from extensive-stage disease compared with FDG. The work is being conducted at a single center (Peking University First Hospital, Beijing) and excludes patients who previously received DLL3-targeted therapy or who cannot undergo PET scanning.
Who should consider this trial
Good fit: Adults with histologically confirmed small cell lung cancer who have at least one measurable lesion, recent labs, and can undergo PET/CT are the ideal candidates.
Not a fit: People who are pregnant or breastfeeding, unable to tolerate PET scanning, or who previously received DLL3-targeted therapy are unlikely to benefit or may be ineligible.
Why it matters
Potential benefit: If successful, PFD3 PET could improve accuracy of SCLC staging and reduce false-positive findings from inflammation, helping clinicians choose the most appropriate local or systemic treatments.
How similar studies have performed: Standard [18F]-FDG PET/CT is well established for SCLC staging, but DLL3-targeted PET agents like PFD3 are novel and have limited prior clinical data in humans.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing Municipality
- Peking university first hospital nuclear medicine — Beijing, Beijing Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Tingting Yuan, M. D.
- Email: biluohtt@163.com
- Phone: +86-13051707479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: SCLC, SCLC, Extensive Stage, SCLC, Limited Stage, Small Cell Lung Cancer, small cell lung cancer, PET/CT, PET, DLL3