Clinical trial · Interventional
68Ga-DOTA-NI-FAPI04 PET/CT in Patients With Various Types of Cancer
NCT06455761CI-TRIAL-00077914unknownEarly 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)
As a novel radiotracer targeting fibroblast activation protein (FAP), 68Ga-DOTA-NI-FAPI04 is a novel agent incorporating a hypoxia sensitive nitroimidazole(NI)-moiety and a FAP-targeting. In this study, we observed the diagnostic performance of 68Ga-DOTA-NI-FAPI04 PET/CT in patients with different types of cancer, and compared its imaging results with those of 68Ga-FAPI or 18F-FDG PET/CT.
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 |
|---|---|---|---|
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-DOTA-NI-FAPI04 | Drug | — | UNRESOLVED |
| 68Ga-FAPI/18F-FDG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 68Ga-DOTA-NI-FAPI04 PET/ CT
- description
- Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-DOTA-NI-FAPI04. Tracer doses of 68Ga-DOTA-NI-FAPI04 will be used to detect tumors by PET/CT.
- interventionNames
- Drug: 68Ga-DOTA-NI-FAPI04
- type
- EXPERIMENTAL
- label
- 68Ga-FAPI/18F-FDG PET/ CT
- description
- Intravenous injection of one dosage of 111-148 MBq (3-4 mCi) 68Ga-FAPI or 3.7 MBq (0.1 mCi)/Kg 18FFDG. Tracer doses of 68Ga-FAPI/18F-FDG will be used to detect tumors by PET/CT.
- interventionNames
- Drug: 68Ga-FAPI/18F-FDG
Primary outcomes (1)
- measure
- Diagnostic value
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Various solid tumors with available histopathological findings; Signed informed consent. Exclusion Criteria: pregnant or lactational women; who suffered from severe hepatic and renal insufficiency.
References
Publications (0)
Data not yet available
No reference posted for this study.