Clinical trial · Interventional
68Ga-FAP-RGD PET/CT : Dosimetry and Preliminary Clinical Translational Studies
68Ga-FAP-RGD PET/CT : Dosimetry and Preliminary Clinical Translational Studies in Cancer Patients
NCT05515783CI-TRIAL-00069826unknownPhase 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 new dual targeting PET radiotracer, 68Ga-FAP-RGD 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-RGD in patients with various types of cancer and compared them with the results of 68Ga-FAPI-02 or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 68Ga-FAP-RGD.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-FAP-RGD | 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 (1min/bed), 30min (2 min/bed), 60min (2 min/bed) and 120min (2 min/bed) after injection
- interventionNames
- Drug: 68Ga-FAP-RGD
- 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-RGD and another agent (68Ga-FAPI-02 or 18F-FDG).
- interventionNames
- Drug: 68Ga-FAP-RGD
Primary outcomes (7)
- measure
- Human biodistribution
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 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 (2)
- DERIVEDChen Y, Zheng S, Zang J, Shao Z, Tu D, Liu Q, Chen X, Miao W, Zhang J. [68Ga]Ga-LNC1007 versus 2-[18F]FDG in the evaluation of patients with metastatic differentiated thyroid cancer: a head-to-head comparative study. Eur J Nucl Med Mol Imaging. 2025 Jan;52(2):683-692. doi: 10.1007/s00259-024-06930-4. Epub 2024 Oct 15. PMID 39404790
- DERIVEDZang J, Lin R, Wen X, Wang C, Zhao T, Jakobsson V, Yang Y, Wu X, Guo Z, Chen X, Zhang J, Miao W. A Head-to-Head Comparison of 68Ga-LNC1007 and 2-18F-FDG/68Ga-FAPI-02 PET/CT in Patients With Various Cancers. Clin Nucl Med. 2023 Oct 1;48(10):861-868. doi: 10.1097/RLU.0000000000004820. Epub 2023 Sep 2. PMID 37682601