NCT06126705

18F-AlF-FAPi-04 PET/CT Imaging in Patients With Solid Tumor

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Affiliated Hospital of North Sichuan Medical College · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the potential usefulness of 18F-AlF-FAPi-04 PET/CT for the diagnosis of primary and metastatic lesions in solid cancer.

Detailed description

This is a prospective, single-center, two arms, open label, non-randomized study to evaluate the ability of 18F-AlF-FAPi-04 to detect FAP expressing cells in patients with solid tumor, evaluate its biological distribution characteristics, impact on clinical treatment plans, and evaluate imaging differences between different probes. Taking histopathology and imaging follow-up as gold standard, the sensitivity, specificity, and accuracy of 18F-AlF-FAPi-04 PET/CT will be calculated.

Conditions

• Tumor, Solid

Interventions

Type	Name	Description
DRUG	Radiation: 18F-AlF-FAPi-04	Subjects who meet all the inclusion criteria will receive intravenous administration of 18F-AlF-FAPi-04 with a dosage range of 0.1-0.2 mCi/Kg. After administration, PET/CT scans will be performed at three time points: 1h, 2h, and 4h post dose. The subjects will also receive administration of 18F-FDG and undergo PET/CT scans for self-control analysis.
DRUG	Radiation: 18F-FDG	Subjects who meet all the inclusion criteria will receive intravenous administration of 18F-AlF-FAPi-04 with a dosage range of 0.1-0.2 mCi/Kg. After administration, PET/CT scans will be performed at three time points: 1h, 2h, and 4h post dose. The subjects will also receive administration of 18F-FDG and undergo PET/CT scans for self-control analysis.

Timeline

• Start date: 2023-07-18
• Primary completion: 2024-05-01
• Completion: 2024-07-01
• First posted: 2023-11-13
• Last updated: 2023-11-13

Locations

1 site across 1 country: China