Using 18F-FAPI-04 PET imaging for cancer diagnosis and monitoring
Official title: Preliminary Study on the Diagnostic Value of 18F-FAPI-04 PET/CT and PET/MR in Patients With Various Types of Malignant Tumors
Run by Hunan Cancer Hospital · NCT06557590 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Hunan Cancer Hospital Academic / other |
| Locations | 1 site (Changsha, Hunan) |
| Status | Recruiting |
| Started | January 1, 2024 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | August 16, 2024 |
| Trial ID | NCT06557590 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with suspected or newly diagnosed malignant tumors who can provide informed consent.
✕Probably not a fit
Patients with non-malignant lesions or those unable to provide informed consent will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
Hunan Cancer hospital
Changsha, Hunan, China Recruiting
Study contacts
- Study coordinator: Hui Ye, PhD
- Email: yehui@hnca.org.cn
- Phone: 13755117105
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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.