Using FAPI-PET imaging to detect tumors
68-Ga-FAPI-PET for Tumor Detection: A Prospective Observational Trial
This study is testing if a new type of imaging called FAPI-PET can help doctors find tumors better in patients who are being checked for cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Essen Academic / other |
| Locations | 1 site (Essen, North Rhine-Westphalia) |
| Trial ID | NCT04571086 on ClinicalTrials.gov |
What this trial studies
This observational trial investigates the effectiveness of 68-Ga-FAPI PET/CT or PET/MRI imaging in detecting tumors in patients undergoing staging or restaging for malignancies. The study aims to correlate imaging results with histopathology, assess the positive predictive value, detection rate, and reproducibility of the imaging technique, and evaluate its impact on clinical management. Data will be collected from patients receiving this imaging modality as part of their routine clinical care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for FAPI-PET imaging for proven or suspected malignancy.
Not a fit: Patients who cannot provide consent, are critically ill, or are unable to tolerate the imaging procedure will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of tumor detection and staging, leading to better treatment decisions for cancer patients.
How similar studies have performed: Other studies using similar PET imaging techniques have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. FAPI-PET scheduled for staging or restaging as part of clinical routine for proven or suspected malignancy 2. Age ≥ 18 years. Exclusion Criteria: 1. Patient cannot give consent for the study 2. Patient can not lie flat or tolerate FAPI PET imaging 3. Unwillingness or inability to comply with study and follow-up procedures 4. Condition of patient which is critical to participate in this study in the discretion of the investigators 5. Pregnant, lactating, or breast feeding women.
Where this trial is running
Essen, North Rhine-Westphalia
- Department of Nuclear medicine, University hospital Essen — Essen, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Principal investigator: Wolfgang Fendler, MD — University Hospital, Essen
- Study coordinator: Wolfgang Fendler, MD
- Email: wolfgang.fendler@uk-essen.de
- Phone: +49 201 723 1862
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.