Clinical trial · Interventional
68Ga-NI-FAPI PET/CT: First-in-human Study
68Ga-NI-FAPI PET/CT: First-in-human Study in Patients With Various Cancers
NCT06688305CI-TRIAL-00082557recruitingEarly 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)
68Ga-NI-FAPI is a novel radiotracer incorporating a hypoxia sensitive nitroimidazole (NI)-moiety and a FAP-targeting. In this study, we observed the safety, biodistribution, radiation dosimetry and diagnostic value of 68Ga-NI-FAPI PET/CT in patients with different types of cancer.
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 |
|---|---|---|---|
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-NI-FAPI | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-NI-FAPI PET/CT
- description
- PET/CT imaging in patients with malignant tumors: each patient underwent a PET/CT scan after intravenous administration of 68Ga-NI-FAPI.
- interventionNames
- Drug: 68Ga-NI-FAPI
Primary outcomes (1)
- measure
- safety and tolerability
- timeFrame
- up to 1 week
- description
- Hematologic status, liver function, renal function and General vital signs were recorded before and 1 week after administration of radiopharmaceutical. Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.
Secondary outcomes (1)
- measure
- Dosimetry of normal organs and tumors
- timeFrame
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 (1)
- DERIVEDZang J, Cheng H, Luo Y, Jin W, Lai Y, Zheng Q, Peng Y, Kung HF, Zhu L, Ke C, Liu C, Miao W. First-in-human study of a novel bifunctional PET tracer [68Ga]Ga-DOTA-NI-FAPI-04 targeting FAP and hypoxia. Eur J Nucl Med Mol Imaging. 2026 Mar;53(4):2530-2539. doi: 10.1007/s00259-025-07625-0. Epub 2025 Oct 31. PMID 41168395