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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04765423
Other study ID # CASE11820
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


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
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