Clinical trial · Interventional
68Ga-FAPI PET/CT in Patients With Various Types of Cancer
68Ga-DOTA/NOTA-FAPI-04 PET/CT in Patients With Various Types of Cancer
NCT04499365CI-TRIAL-00118778recruitingEarly 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)
To evaluate the potential usefulness of 68Ga-DOTA/NOTA-FAPI-04 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer.
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 |
|---|---|---|---|
| Metastasis | — | UNRESOLVED | — |
| Positron-Emission Tomography | — | UNRESOLVED | — |
| Tumor | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-DOTA/NOTA-FAPI-04 | Drug | — | UNRESOLVED |
| PET/CT scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: 68Ga-DOTA/NOTA-FAPI-04
- description
- Each subject receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT imaging within the specificed time.
- interventionNames
- Drug: 68Ga-DOTA/NOTA-FAPI-04
- Diagnostic Test: PET/CT scan
Primary outcomes (1)
- measure
- Standardized uptake value (SUV)
- timeFrame
- 30 days
- description
- Standardized uptake value (SUV) of 68Ga-DOTA/NOTA-FAPI-04 for each target lesion of subject or suspected primary tumor or/and metastasis.
Secondary outcomes (2)
- measure
- Diagnostic efficacy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled 68Ga-DOTA/NOTA-FAPI-04 PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee. Exclusion Criteria: * (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
References
Publications (3)
- DERIVEDZheng S, Lin J, Zhu Y, Chen Y, Zhang J, Chen X, Miao W. 68Ga-FAPI Versus 18F-FDG PET/CT in Evaluating Newly Diagnosed Breast Cancer Patients: A Head-to-Head Comparative Study. Clin Nucl Med. 2023 Mar 1;48(3):e104-e109. doi: 10.1097/RLU.0000000000004523. Epub 2023 Jan 10. PMID 36723892
- DERIVEDChen Y, Zheng S, Zhang J, Yao S, Miao W. 68Ga-DOTA-FAPI-04 PET/CT imaging in radioiodine-refractory differentiated thyroid cancer (RR-DTC) patients. Ann Nucl Med. 2022 Jul;36(7):610-622. doi: 10.1007/s12149-022-01742-8. Epub 2022 May 12. PMID 35551610
- DERIVEDZheng S, Lin R, Chen S, Zheng J, Lin Z, Zhang Y, Xue Q, Chen Y, Zhang J, Lin K, You X, Yao S, Miao W. Characterization of the benign lesions with increased 68Ga-FAPI-04 uptake in PET/CT. Ann Nucl Med. 2021 Dec;35(12):1312-1320. doi: 10.1007/s12149-021-01673-w. Epub 2021 Aug 23. PMID 34424505