NCT04990882

FAPI PET/CT Prospective Interobserver Agreement

FAPI PET/CT Imaging for Cancer: A Prospective Interobserver Agreement Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: University Hospital, Essen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the present study is to evaluate the interobserver agreement for FAPI PET/CT interpretations of representative cancer types and compare findings among readers with different levels of experience.

Detailed description

Fibroblast activation protein (FAP) is expressed by many cancer-associated fibroblasts, having a pivotal role in many desmoplastic tumor histotypes (sarcoma, pancreatic cancer, colorectal cancer). 68Ga-FAPI inhibitor (FAPI) is a promising novel molecular imaging tracer for positron emission tomography with computed tomography (PET/CT), with favorable initial results in different tumor entities. Compared to 18F-FDG, 68Ga-FAPI PET/CT shows a similar biodistribution, with less background tracer uptake in the brain, oral mucosa and liver, thus making this tracer potentially suitable to detect tumor lesions in these regions. Moreover, the FAPI ligand contains a DOTA peptide which makes it appropriate also for therapeutic options if linked with 177Lutetium or 90Yttrium. There is an increasing number of trials aimed to assess the efficacy and the clinical impact of 68Ga-FAPI PET/CT. Therefore, the inter-observer agreement and variability with 68Ga-FAPI PET/CT need to be established.

Conditions

• Malignant Neoplasm

Interventions

Type	Name	Description
OTHER	Interpretation of FAPI-PET/CT scans	Each observer's Group will be asked to review FAPI-PET/CT scans of patients with representative cancer types.

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-10-30
• Completion: 2022-10-30
• First posted: 2021-08-05
• Last updated: 2022-11-03

Locations

1 site across 1 country: Germany