Using 18F-FAPI-04 PET imaging for cancer diagnosis and monitoring
Preliminary Study on the Diagnostic Value of 18F-FAPI-04 PET/CT and PET/MR in Patients With Various Types of Malignant Tumors
Hunan Cancer Hospital · NCT06557590
This study is testing a new type of imaging called 18F-FAPI-04 PET to see if it can help doctors better diagnose and monitor different kinds of cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Hunan Cancer Hospital (other) |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT06557590 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of 18F-FAPI-04 positron emission tomography/computed tomography (PET/CT) and PET/magnetic resonance imaging (PET/MR) in diagnosing primary and metastatic cancer lesions, detecting recurrences, and assessing treatment responses. Patients with various types of malignant tumors will undergo imaging to quantify tumor uptake and compare results against histopathology and follow-up data. The study aims to calculate the sensitivity, specificity, and accuracy of these imaging techniques in a clinical setting.
Who should consider this trial
Good fit: Ideal candidates include patients with suspected or newly diagnosed malignant tumors who can provide informed consent.
Not a fit: Patients with non-malignant lesions or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of cancer diagnosis and monitoring, leading to better treatment outcomes for patients.
How similar studies have performed: While the use of PET imaging in cancer diagnosis is established, the specific application of 18F-FAPI-04 is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); 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: patients with non-malignant lesions; patients with pregnancy; the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Where this trial is running
Changsha, Hunan
- Hunan Cancer hospital — Changsha, Hunan, China (RECRUITING)
Study contacts
- Study coordinator: Hui Ye, PhD
- Email: yehui@hnca.org.cn
- Phone: 13755117105
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.