Clinical trial · Interventional
68Ga-TCR-FAPI PET/CT in Patients With Various Types of Cancer
Evaluating the Clinical Value of 68Ga-TCR-FAPI PET/CT in Patients With Various Types of Cancer
NCT06084767CI-TRIAL-00070672unknownN/AClinicalTrials.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)
Adding targeted covalent radiopharmaceutical (TCR) moiety to fibroblast activation protein inhibitor (FAPI) can increase tumor uptake and tumor retention in pre-clinical studies. This study is an open-labeled single-arm phase II diagnostic clinical trial to explore the clinical value of 68Ga-TCR-FAPI PET/CT in suspected malignant tumor patients.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibroblast Activation Protein Inhibitor | — | UNRESOLVED | — |
| Malignant Tumor | Malignant Neoplasm | ALIAS | 0.90 |
| Positron Emission Tomography | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-TCR-FAPI PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Malignant tumors
- description
- This arm investigated the clinical value of 68Ga-TCR-FAPI PET/CT in suspected malignant tumors.
- interventionNames
- Diagnostic Test: 68Ga-TCR-FAPI PET/CT
Primary outcomes (1)
- measure
- Diagnostic accuracy
- timeFrame
- 90 days
- description
- The sensitivity, specificity, and accuracy of 68Ga-TCR-FAPI PET/CT to detect tumor lesions were calculated to evaluate the diagnostic efficacy.
Secondary outcomes (1)
- measure
- Tumor uptake
- timeFrame
- 90days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Suspected to have malignant tumors (supported by MRI and/or CT and/or tumor markers and/or pathology report), the tumor may be newly diagnosed or previously treated; * Meet the indications for PET examination, show a clear indication and no contraindications; * Have a performance status of score ≥ 80 on KPS scale or score 0-1 points on ECOG scale, a relatively good general situation; * No major organ dysfunction (heart, lung, liver, kidney and other major organ include), acute or life-threatening status of infection; * Be ≥ 18 years of age; * Be willing and able to understand the research content and provide written informed consent/assent for the trial. Exclusion Criteria: * Have a history of imaging agent allergies; * Does not meet the PET-CT scan sedation requirements, or has contraindications for PET-CT examination; * Be pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
References
Publications (1)
- DERIVEDCui XY, Li Z, Kong Z, Liu Y, Meng H, Wen Z, Wang C, Chen J, Xu M, Li Y, Gao J, Zhu W, Hao Z, Huo L, Liu S, Yang Z, Liu Z. Covalent targeted radioligands potentiate radionuclide therapy. Nature. 2024 Jun;630(8015):206-213. doi: 10.1038/s41586-024-07461-6. Epub 2024 May 22. PMID 38778111