Clinical trial · Interventional
68Ga-FAP-CHX PET/CT : Dosimetry and Preliminary Clinical Translational Studies
NCT05506566CI-TRIAL-00069722unknownPhase 1 / Phase 2ClinicalTrials.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 an emerging molecule targeting FAP, 68Ga-FAP-CHX is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-FAP-CHX in patients with various types of cancer and compared them with the results of 68Ga-FAPI-04 or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 68Ga-FAP-CHX.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Positron-Emission Tomography | — | UNRESOLVED | — |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-FAP-CHX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part I: safety, tolerability, biodistribution and dosimetry
- description
- PET imaging will begin at 30s (30s/bed), 15min (1 min/bed), 30min (2 min/bed), 60min (2 min/bed) and 120min (2 min/bed) after injection, and whole-body low-dose CT needed to be re-acquired at 120 minutes
- interventionNames
- Drug: 68Ga-FAP-CHX
- type
- EXPERIMENTAL
- label
- Part II: diagnostic efficacy
- description
- Participants with various types of cancer will have PET imaging 50-100 minutes after injection of 68Ga-FAP-CHX and another agent (68Ga-FAPI-04 or 18F-FDG).
- interventionNames
- Drug: 68Ga-FAP-CHX
Primary outcomes (7)
- measure
- Human biodistribution
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years \< Age \< 75 years * Various solid tumors with available histopathological findings, and have not been treated surgically. * Signed informed consent. Exclusion Criteria: * patients with pregnancy * the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.