Using a new imaging agent to diagnose various cancers
68Ga-DOTA-NI-FAPI04 PET/CT in Patients With Various Types of Cancer
This study is testing a new imaging agent to see if it can help doctors better diagnose and stage different types of cancer by focusing on specific cells in tumors.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Fujian Medical University Academic / other |
| Locations | 1 site (Fuzhou) |
| Trial ID | NCT06455761 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the diagnostic performance of a novel radiotracer, 68Ga-DOTA-NI-FAPI04, which targets fibroblast activation protein (FAP) in patients with different types of cancer. The study compares the imaging results of this new agent with existing tracers like 68Ga-FAPI and 18F-FDG PET/CT. By focusing on carcinoma-associated fibroblasts, which are prevalent in many malignant tumors, the trial aims to improve tumor staging and restaging accuracy. Participants will undergo PET/CT scans to assess the effectiveness of this innovative imaging approach.
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 study could enhance the accuracy of cancer diagnosis and staging, leading to better treatment planning.
How similar studies have performed: Previous studies using other FAP-targeting tracers have shown promising results, indicating 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
- The First Affiliated Hospital of Fujian Medical University — Fuzhou, China (Recruiting)
Study contacts
- Principal investigator: Weibing Weibing, 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.