Clinical trial · Interventional
Diagnosis of Metastatic Tumors on 68Ga-FAPI PET-CT and Radioligand Therapy with 177Lu-EB-FAPI
NCT05400967CI-TRIAL-00080716recruitingEarly 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)
FAP is a fibroblast activation protein and overexpressed in many tumor tissues. This study is intended to conduct preliminary clinical transformation and internal irradiation dosimetry research on 177Lu-EB-FAPI--a new 177Lu therapeutic drug modified by Evans Blue (EB) for the first time in the world.
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 |
|---|---|---|---|
| 177Lu-EB-FAPI | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-FAPI for PET / CT scan and 177Lu-EB-FAPI for therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-FAPI PET/CT for scan and 177Lu-EB- FAPI for therapy
- description
- All patients diagnosed with metastatic tumors underwent 68Ga-FAPI PET/CT scan. If the PET/CT showed high FAPI expression in tumor lesions of some patients, they would intravenously injected with the dose about 2.22GBq (60 mCi) of 177Lu-EB-FAPI for therapy.
- interventionNames
- Drug: 68Ga-FAPI for PET / CT scan and 177Lu-EB-FAPI for therapy
Primary outcomes (2)
- measure
- Safety of therapy
- timeFrame
- through study completion, an average of 1 year
- description
- the safety assessed by CTCAE v4.0
- measure
- Therapeutic effect
- timeFrame
- through study completion, an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * confirmed treated or untreated metastatic tumors patients; * 68Ga-FAPI PET/CT and 18F-FDG PET/CT within two weeks; * signed written consent. Exclusion Criteria: * pregnancy; * breastfeeding; * any medical condition that in the opinion of the investigator may significantly interfere with study compliance
References
Publications (0)
Data not yet available
No reference posted for this study.