Clinical trial · Interventional
68Ga-FAPI-04 PET/CT for the Detection of Oral Carcinoma
NCT05003427CI-TRIAL-00061780unknownEarly Phase 1ClinicalTrials.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)
FAPI is a fibroblast activation protein inhibitor and 68Ga-FAPI-04 is a potential new imaging agent for imaging of carcinoma. 68Ga-FAPI-04 PET/CT is helpful to clarify the benign, malignant and invasive range of the oral carcinoma, locate and qualitatively diagnose the tumor, and make early diagnosis and restaging of recurrent tumor.
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 |
|---|---|---|---|
| Oral Carcinoma | Lip and Oral Cavity Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-FAPI-04 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-FAPI-04 PET/CT
- description
- The patients were injected with 55.5-148 MBq (1.5-4mCi) of 68Ga-FAPI-04 in one dose intravenously and underwent SPECT/CT scan 30-90 min later.
- interventionNames
- Drug: 68Ga-FAPI-04
Primary outcomes (2)
- measure
- Diagnostic performance1
- timeFrame
- 1 year
- description
- comparing the SUV and number of Oral cancer or metastasis detected by 68Ga-FAPI-04 and 18F-FDG PET/CT
- measure
- Diagnostic performance2
- timeFrame
- 1 year
- description
- comparing the SUV and number of Oral cancer or metastasis detected by 68Ga-FAPI-04 and 18F-FDG PET/CT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * patients in suspicion of oral carcinoma, * 68Ga-FAPI-04 and 18F-FDG PET/CT within 2 week; * being able to provide basic information and sign the written informed consent form. Exclusion Criteria: * claustrophobia, * pregnancy, * breastfeeding, * kidney or liver failure, * inability to fulfill the study.
References
Publications (0)
Data not yet available
No reference posted for this study.