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Poor patient accrual
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NaF PET/CT scan and F-18 fluciclovine PET/CT | Experimental | Visit 1: Participant receives a whole body [F-18] NaF PET/CT (diagnostic study) Visit 2: Participant receives a whole body [F-18] fluciclovine PET/CT within 3 weeks of Visit 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [F-18] NaF PET/CT | Device | Radiotracer F-18 NaF used on the PET/CT imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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)
| At time of scan, up to 60 minutes per scan |
| 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 |
| 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 |
| 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 |
| 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 |
| Area under the curve (AUC) |
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Inclusion Criteria:
Exclusion Criteria:
-Cannot tolerate imaging up to 60 minutes of total imaging
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| Name | Affiliation | Role |
|---|---|---|
| Robert Jones, MD | University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
No current plans to share IPD
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| [F-18] fluciclovine PET/CT | Device | F-18 fluciclovine (Axumin ®) used on the PET/CT camera |
|
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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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |