Interreader and Intrareader Reproducibility of ¹⁸F-Flotufolastat Image Interpretation in Patients with Newly...

Area of Science:

• Nuclear Medicine
• Radiology
• Oncology

Background:

• Prostate cancer diagnosis and staging rely on accurate imaging.
• 18F-flotufolastat Positron Emission Tomography/Computed Tomography (PET/CT) is an emerging imaging modality.
• Assessing the reliability of 18F-flotufolastat PET/CT interpretation is crucial for clinical adoption.

Purpose of the Study:

• To evaluate the interreader and intrareader reproducibility of 18F-flotufolastat PET/CT scan interpretations.
• To assess the reliability of image analysis in both newly diagnosed and recurrent prostate cancer patients.

Main Methods:

• Masked image evaluations of 18F-flotufolastat PET/CT scans from two Phase 3 studies involving 352 newly diagnosed and 389 recurrent prostate cancer patients.
• Three masked readers assessed images, utilizing Cohen κ for pairwise agreement and Fleiss κ for overall agreement.
• Intrareader agreement was assessed by comparing initial reads with repeat reads (20% of images) conducted at least 4 weeks later.

Main Results:

• High pairwise interreader agreement was observed: ≥95% in newly diagnosed and ≥75% in recurrent prostate cancer patients.
• Agreement was highest in the prostate for newly diagnosed patients (≥95%) and pelvic lymph nodes for recurrent patients (≥87%).
• Intrareader agreement exceeded 86% across both patient populations, indicating consistent individual interpretation.

Conclusions:

• 18F-flotufolastat PET/CT imaging demonstrates a high degree of reliability in interpretation.
• The study confirms substantial inter- and intrareader agreement, supporting its clinical utility in prostate cancer management.