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

Malignant Neoplasm of Prostate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04765423
• Other study ID #: CASE11820
• Status: Withdrawn
• Phase: N/A
• Start date: March 25, 2021
• Est. completion date: March 18, 2022

Study information

• Verified date: March 2022
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 18, 2022
• Est. primary completion date: March 18, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Referred for initial staging or restaging of prostate cancers with clinical suspicion of bone metastases.
• Must understand and voluntarily sign an Informed Consent Document Exclusion Criteria: -Cannot tolerate imaging up to 60 minutes of total imaging

Related Conditions & MeSH terms

• Malignant Neoplasm of Prostate
• Neoplasm Metastasis
• Neoplasms
• Prostatic Neoplasms

Intervention

Device:
• [F-18] NaF PET/CT
Radiotracer F-18 NaF used on the PET/CT imaging
• [F-18] fluciclovine PET/CT
F-18 fluciclovine (Axumin ®) used on the PET/CT camera

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of lesions seen by [F-18] NaF PET/CT which are also seen by [F-18] fluciclovine PET/CT	Agreement of imaging methods as measured by number of lesions seen by [F-18] NaF PET/CT which are also seen by [F-18] fluciclovine PET/CT broken down by diagnostic score on a lesion-by-lesion basis (1 to 5); Definitely benign; Probably benign; Equivocal; Probably malignant; Definitely malignant	At time of scan, up to 60 minutes per scan
Primary	Sensitivity	Accuracy of [F-18] fluciclovine PET/CT compared to [F-18] NaF PET/CT evaluated via sensitivity; Sensitivity is the number of true positives (TP) divided by the sum of TP and false negatives (FN): Sensitivity = TP / (TP+FN)	At time of scan, up to 60 minutes per scan
Primary	Specificity	Accuracy of [F-18] fluciclovine PET/CT compared to [F-18] NaF PET/CT evaluated via specificity; Specificity is the number of true Negatives (TN) divided by the sum of TN and false positives (FP): Sensitivity = TN / (TN+FP)	At time of scan, up to 60 minutes per scan
Primary	Positive Predictive Value (PPV)	Accuracy of [F-18] fluciclovine PET/CT compared to [F-18] NaF PET/CT evaluated via PPV; PPV is the number of true TP divided by the sum of TP and FP: Sensitivity = TP / (TP+FP)	At time of scan, up to 60 minutes per scan
Primary	Negative Predictive Value (NPV)	Accuracy of [F-18] fluciclovine PET/CT compared to [F-18] NaF PET/CT evaluated via NPV; NPV is the number of true TN divided by the sum of TN and FN: Sensitivity = TN / (TN+FN)	At time of scan, up to 60 minutes per scan
Primary	Area under the curve (AUC)	Accuracy of [F-18] fluciclovine PET/CT compared to [F-18] NaF PET/CT evaluated via AUC using Receiver Operating Characteristic (ROC) curves	At time of scan, up to 60 minutes per scan