Evaluating FAPI PET/MR with Gadoxetate for Liver Cancer Assessment
Role of FAPI PET/MR Combined With Gadoxetate Disodium in Assessing Hepatic Malignancies
This study is testing a new imaging method using FAPI PET/MR with a special contrast agent to see if it can better detect liver cancer in patients who might have it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Daping Hospital and the Research Institute of Surgery of the Third Military Medical University Academic / other |
| Locations | 1 site (Chongqing, Chongqing) |
| Trial ID | NCT06287411 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of fibroblast activation protein inhibitor (FAPI) positron emission tomography (PET) combined with magnetic resonance imaging (MR) using gadoxetate disodium in patients suspected of having hepatic malignancies. Participants will undergo both FAPI and fluorodeoxyglucose (FDG) PET/MR imaging, along with clinical and biological data collection, to assess the imaging's diagnostic capabilities. The study will also include pathological analysis of biopsy or surgical specimens to validate imaging findings against histopathological results.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with suspected or diagnosed liver cancer and adequate kidney function.
Not a fit: Patients with contraindications to MRI, such as those with certain implants or claustrophobia, or those allergic to gadoxetate disodium may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the accuracy of diagnosing hepatic malignancies, leading to better treatment decisions for patients.
How similar studies have performed: While the combination of FAPI PET/MR and gadoxetate disodium is a novel approach, similar imaging techniques have shown promise in other malignancies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient ≥ 18 years of age at the time of consent; 2. Patients with suspected, newly diagnosed, or previously treated liver cancer; 3. Estimated creatinine clearance \> 30ml/min; 4. Provided written informed consent authorisation before participating in the study. Exclusion Criteria: 1. Allergic to the gadoxetate disodium； 2. MRI contraindications, not limited to cardiac implantable electronic devices and claustrophobia; 3. Weight \> 90Kg; 4. Pregnancy or lactation; 5. Active inflammation may affect FAPI imaging.
Where this trial is running
Chongqing, Chongqing
- Department of Nuclear Medicine, Daping Hospital of Army Medical University — Chongqing, Chongqing, China (Recruiting)
Study contacts
- Principal investigator: Xiao Chen, Ph.D — Daping Hospital, Army Medical University
- Study coordinator: Xiao Chen, Ph.D
- Email: xiaochen229@foxmail.com
- Phone: +8615922970174
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.