Clinical trial · Interventional
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)
NCT07508852CI-TRIAL-00115176recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| SCLC | Lung Small Cell Carcinoma | ALIAS | 0.90 |
| SCLC, Extensive Stage | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| SCLC, Limited Stage | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
| Small Cell Lung Cancer ( SCLC ) | Lung Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]Ga-PFD3 PET/CT scan | Diagnostic Test | — | UNRESOLVED |
| Sequential [18F]-FDG PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Eligible participants
- description
- Sequential \[18F\]-FDG PET/CT and \[68Ga\]Ga-PFD3 PET/CT
- interventionNames
- Diagnostic Test: Sequential [18F]-FDG PET/CT
- Diagnostic Test: [68Ga]Ga-PFD3 PET/CT scan
Primary outcomes (2)
- measure
- Adverse events (assessed using CTCAE grades)
- timeFrame
- 1 week after injection
- description
- 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.
- measure
- Correlation between PFD3 uptake and DLL3 expression
- timeFrame
- Baseline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.