Comparing two imaging methods for detecting malignant tumors
Head-to-head Comparison of Positron Nuclide Radio-labeled FAPI and 18F-FDG PET/CT in Patients With Malignant Tumors
This study is testing whether a new type of imaging called FAPI PET/CT can find tumors better than the standard FDG PET/CT in patients with different types of cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Guangdong Provincial People's Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06182644 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of positron-labeled FAP inhibitors (FAPI PET/CT) against the traditional 18F-FDG PET/CT in patients with various malignant tumors, including renal cell carcinoma and gastric cancer. The goal is to determine which imaging method provides better visualization of tumor stroma, particularly in cases where FDG PET/CT has shown poor results. Patients who meet specific criteria will undergo both imaging techniques to assess the presence and extent of their tumors, aiding in personalized treatment planning.
Who should consider this trial
Good fit: Ideal candidates include patients with a high suspicion of malignant tumors who have not yet undergone surgery or chemotherapy.
Not a fit: Patients who have recently undergone radiotherapy or chemotherapy, or those who cannot tolerate biopsy procedures, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection and treatment planning for patients with difficult-to-diagnose malignant tumors.
How similar studies have performed: While previous studies have shown promising results for FAPI PET/CT, this specific head-to-head comparison is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with high clinical suspicion of malignant tumors; 2. Those who have undergone endoscopic biopsy or puncture biopsy indicating malignant tumors but have not undergone surgery or chemotherapy; 3. Previous history of malignant tumor surgery, suspected of recurrence or distant metastasis; 4. There is a willingness for puncture biopsy or surgery, and there are no contraindications for puncture biopsy or surgery, and there are no contraindications for anesthesia; 5. Sign an informed consent form and undergo a nuclear medicine examination, without any contraindications, with the ability and willingness to participate in the follow-up plan. Exclusion Criteria: 1. Those who cannot tolerate puncture biopsy or surgical contraindications; 2. Those who have undergone radiotherapy and chemotherapy in the past 3 months; 3. Individuals who are allergic to multiple drugs or foods; 4. Those who refuse nuclear medicine examinations; 5. Those who do not agree to sign an informed consent form and are unable or willing to follow up.
Where this trial is running
Guangzhou, Guangdong
- Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Recruiting)
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.