NCT04416165

Comparison of FDG and FAPI in Patients With Various Types of Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: The First Affiliated Hospital of Xiamen University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the potential usefulness of 68Ga-DOTA-FAPI-04 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, compared with 18F-FDG PET/CT.

Detailed description

Subjects with various types of cancer underwent contemporaneous 68Ga-DOTA-FAPI-04 and 18F-FDG PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FDG and 68Ga-DOTA-FAPI-04 PET/CT were calculated and compared to evaluate the diagnostic efficacy.

Conditions

• Tumor, Solid
• Positron-Emission Tomography
• Metastasis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	18F-FDG and 68Ga-DOTA-FAPI -04 PET/CT	Each subject receive a single intravenous injection of 18F-FDG and 68Ga-DOTA-FAPI-04, and undergo PET/CT imaging within the specified time.

Timeline

• Start date: 2019-10-20
• Primary completion: 2027-12-30
• Completion: 2027-12-30
• First posted: 2020-06-04
• Last updated: 2023-08-08

Locations

1 site across 1 country: China