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
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Status | Withdrawn |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 |
Verified date | March 2022 |
Source | Case Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
United States | University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center |
United States,
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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