68Ga-FAPI PET/CT imaging to detect primary and metastatic cancer lesions
Official title: 68Ga-DOTA/NOTA-FAPI-04 PET/CT in Patients With Various Types of Cancer
Run by First Affiliated Hospital of Fujian Medical University · NCT04499365 · Data updated 2026-11-12
This study tests whether 68Ga-DOTA/NOTA-FAPI-04 PET/CT can help find primary tumors and metastases in adults with various cancers.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | First Affiliated Hospital of Fujian Medical University Academic / other |
| Locations | 1 site (Fuzhou, Fujian) |
| Status | Recruiting |
| Started | August 15, 2020 |
| Main results expected | December 30, 2027 |
| Study ends | December 30, 2027 |
| Registry record updated | July 21, 2026 |
| Trial ID | NCT04499365 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with suspected, newly diagnosed, or previously treated malignant tumors who are scheduled for 68Ga-DOTA/NOTA-FAPI-04 PET/CT imaging and can provide informed consent.
✕Probably not a fit
Patients with non-malignant lesions, pregnancy, or inability to consent may not benefit from this imaging test.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early-phase trial evaluates the diagnostic utility of 68Ga-DOTA/NOTA-FAPI-04 PET/CT for identifying primary and metastatic cancer lesions. Patients with suspected, newly diagnosed, or previously treated malignancies undergo PET/CT imaging to measure tumor uptake using SUVmax and to estimate sensitivity, specificity, PPV, NPV, and overall accuracy. The study analyzes how well this imaging modality detects cancer compared with existing diagnostic information. Procedures involve a single PET/CT scan using the radiotracer 68Ga-DOTA/NOTA-FAPI-04. The lead site is the First Affiliated Hospital of Fujian Medical University in Fuzhou, China, with no listed collaborators.
Why it matters
Potential benefit: If successful, this imaging approach could improve accuracy in locating primary and metastatic tumors, potentially guiding treatment decisions.
How similar studies have gone: Prior work in related FAPI PET tracers has shown promise in tumor imaging, but this specific tracer and protocol are being evaluated for diagnostic performance in this study.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China Recruiting
Study contacts
- Study coordinator: Weibing Miao, MD
- Email: miaoweibing@126.com
- Phone: 86-0591-87981618
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.