Clinical trial · Interventional
Study of 64Cu-FAPI-XT117 PET/CT in Patients With Malignant Solid Tumors
NCT05930457CI-TRIAL-00072516completedPhase 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)
This is the study of 64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study.
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 Solid Tumors | Malignant Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2.5-3.5mCi 64Cu-FAPI-XT117 | Drug | — | UNRESOLVED |
| 3.5-4.5mCi 64Cu-FAPI-XT117 | Drug | — | UNRESOLVED |
| 4.5-5.5mCi 64Cu-FAPI-XT117 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 64Cu-FAPI-XT117 PET/CT
- interventionNames
- Drug: 2.5-3.5mCi 64Cu-FAPI-XT117
- Drug: 3.5-4.5mCi 64Cu-FAPI-XT117
- Drug: 4.5-5.5mCi 64Cu-FAPI-XT117
Primary outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- timeFrame
- 7 days following injection]
- description
- Evaluation of Adverse Events (AE) Using CTCAE
Secondary outcomes (2)
- measure
- The diagnostic efficacy of 64Cu-FAPI-XT injection in PET/CT imaging of patients with malignant solid tumor
- timeFrame
- 2 months following injection
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. signed the informed consent * 2\. ≥18 years old * 3\. confirmed as malignant solid tumor by histopathology or clinical judgment * 4\. Patients will undergo 18F-FDG PET/CT examination Exclusion Criteria: * 1\. Known allergy to components of the investigational drug or its analogues * 2\. suspected to have a certain disease or condition that is not suitable for the study drug * 3\. Known pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.