First use of 68Ga-NI-FAPI PET/CT for cancer diagnosis
68Ga-NI-FAPI PET/CT: First-in-human Study in Patients With Various Cancers
This study is testing a new imaging agent called 68Ga-NI-FAPI to see if it can help doctors better spot different types of cancer using PET/CT scans.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Fujian Medical University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT06688305 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and diagnostic effectiveness of a new radiotracer, 68Ga-NI-FAPI, in patients with various types of cancer. The radiotracer targets carcinoma-associated fibroblasts, which are commonly overexpressed in malignant tumors. The study aims to assess how well this new agent can visualize tumors using PET/CT imaging, along with its biodistribution and radiation dosimetry. By focusing on a specific marker found in over 90% of epithelial malignant tumors, this approach could enhance cancer diagnosis and management.
Who should consider this trial
Good fit: Ideal candidates include patients with various solid tumors who have confirmed histopathological findings.
Not a fit: Patients who are pregnant, lactating, or have severe hepatic and renal insufficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to improved diagnostic accuracy for various cancers, allowing for better treatment planning.
How similar studies have performed: Previous studies using other FAP-targeting tracers have shown promising results in cancer diagnostics, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Fuzhou, Fujian
- Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Principal investigator: Weibing Miao, MD — First Affiliated Hospital of Fujian Medical University
- Study coordinator: Weibing Miao, MD
- Email: miaoweibing@126.com
- Phone: +86-0591-87981618
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.