Clinical trial · Interventional
Comparison of 68Ga-FAPI-46 PET and 18F-FDG PET in Lung Cancer
68Ga-FAPI PET in Evaluation of the Patient With Known or Suspected Lung Cancer: Comparison With Standard 18F-FDG PET
NCT05617742CI-TRIAL-00111439completedN/AClinicalTrials.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 is a prospective, single-center, single arm, open label study to evaluate the performance of 68Ga-FAPI-46 for the diagnosis of primary and metastatic lesions of lung cancer with comparison to 18F-FDG PET.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-FAPI-46 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-FAPI-46 PET Scan
- description
- A single-center prospective interventional single-arm clinical trial. All patients will undergo whole-body 68Ga-FAPI-46 PET scan within two weeks before or after 18F-FDG-PET. Injected activity of 68Ga-FAPI-46 is limited to 100-250 MBq per examination.
- interventionNames
- Diagnostic Test: 68Ga-FAPI-46
Primary outcomes (1)
- measure
- To define the diagnostic performance 68Ga-FAPI PET
- timeFrame
- Through study completion, 2 years
- description
- To evaluate the diagnostic performance (sensitivity, specificity, accuracy) of the 68Ga-FAPI-46 PET scan for identification and staging of lung cancer with comparison to 18F-FDG PET. Histopathology and clinical follow-up will be used as truth standard.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \> 20 years 2. Informed consent obtained from patients and families 3. Patients with histology confirmed lung cancer or patients with GGO on chest CT planned to have biopsy or surgery 4. Patients scheduled to undergo FDG-PET examination 5. Performance status: 0, 1, 2, 3 Exclusion Criteria: 1. Contraindication to FAPI-PET and FDG-PET such as pregnant, or lactating patients 2. Patients with mainly malignant pleural effusion without other measurable lesions 3. Undergoing irradiation at accrual 4. Active infection or other serious underlying medical conditions not compatible with study entry 5. History of significant neurological or psychiatric disorders including dementia that would prohibit the understanding and giving of informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.