NCT06557590

18F-FAPI-04 PET/CT and PET/MR in Patients With Various Types of Malignant Tumors

Preliminary Study on the Diagnostic Value of 18F-FAPI-04 PET/CT and PET/MR in Patients With Various Types of Malignant Tumors

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Hunan Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

To evaluate the potential usefulness of 18F-FAPI-04 positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance imaging （PET/MR）for the diagnosis of primary and metastatic lesions, detection of recurrence or assessment of pathologic response in various types of cancer.

Detailed description

Subjects with various types of cancer underwent 18F-FAPI-04 PET/CT and PET/MR imaging either for an initial assessment, recurrence detection or assessment of pathologic response. Tumor uptake was quantified by the maximum standard uptake value (SUVmax) and tumor to background (TBR). Using histopathology and follow-up as gold standard, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FAPI-04 PET/CT and PET/MR were calculated.

Conditions

• Cancer
• FAP

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	18F-FAPI-04	18F-FAPI-04 was injected into the patients before the PET/CT or PET/MR scans

Timeline

• Start date: 2024-01-01
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2024-08-16
• Last updated: 2024-08-16

Locations

1 site across 1 country: China