NCT04765423

Fluciclovine (Axumin) PET/CT vs. NaF PET/CT in Prostate Cancer Osseous Metastatic Disease

[F-18] Fluciclovine (Axumin) PET/CT vs. [F-18] NaF PET/CT in the Evaluation of Prostate Cancer Osseous Metastatic Disease

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to look at whether F-18 Fluciclovine (i.e. Axumin) is better or as good as F-18 Sodium Fluoride (F-18 NaF) when looking at bone disease from prostate cancer. Axumin is a radioactive agent used on a positron/computed tomography (PET/CT) camera to look for prostate cancer in general.

Detailed description

The study will assess the diagnostic performance of \[F-18\] fluciclovine PET/CT compared to \[F-18\] NaF PET/CT as the reference standard. Each bone lesion identified on \[F-18\] NaF PET/CT will be compared with the level of \[F-18\] fluciclovine uptake The primary objective is to assess \[F-18\] fluciclovine efficacy in the evaluation of osseous metastatic disease in prostate cancer on a lesion-by-lesion comparison with \[F-18\] NaF as a the reference standard.

Conditions

• Malignant Neoplasm of Prostate

Interventions

Type	Name	Description
DEVICE	[F-18] NaF PET/CT	Radiotracer F-18 NaF used on the PET/CT imaging
DEVICE	[F-18] fluciclovine PET/CT	F-18 fluciclovine (Axumin ®) used on the PET/CT camera

Timeline

• Start date: 2021-03-25
• Primary completion: 2022-03-18
• Completion: 2022-03-18
• First posted: 2021-02-21
• Last updated: 2022-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study