Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer

Study Overview
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Brief Summary
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This clinical trial studies fluorine F-18 sodium fluoride positron emission tomography (PET)/computed tomography (CT) in diagnosing bone tumors in patients with cancer. Diagnostic procedures, such as fluorine F-18 sodium fluoride PET/CT, may help find and diagnose bone cancer

Detailed Description
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The objective of the study is to use 18F sodium fluoride (fluorine F-18 sodium fluoride) PET/CT scanning to detect and characterize lesions in patients who have suspected skeletal malignancy. We hypothesize that scanning with 18F-NaF (fluorine F-18 sodium fluoride) is more sensitive for skeletal abnormalities and may better characterize lesions than conventional imaging.

Official Title
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Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer

Conditions
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Bone Cancer

Intervention / Treatment
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* Radiation: fluorine F 18 sodium fluoride
* Procedure: positron emission tomography/computed tomography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients referred for evaluation of suspected skeletal cancer Patients must understand and voluntarily sign an informed consent form after the contents have been fully explained to them Exclusion Criteria: Patients who cannot complete a PET/CT scan Pregnant women Healthy volunteers

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (fluorine F 18 sodium fluoride PET/CT)<br>Patients undergo fluorine F 18 sodium fluoride PET/CT scan. | Radiation: fluorine F 18 sodium fluoride<br>* Undergo fluorine F 18 sodium fluoride PET/CT scan<br>* Other names: F-18 NaF;Procedure: positron emission tomography/computed tomography<br>* Undergo fluorine F 18 sodium fluoride PET/CT scan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Lesions Identified by F-18 NaF PET/CT in Patients With Suspected Skeletal Malignancy | F-18 NaF is a positron emission tomography (PET) bone imaging agent that targets changes in the bone. The fluoride ions are taken up in areas of the bone that have increased bone remodeling (bone repair) and increased blood flow, which is indicative of diseases such as cancer. | an estimated average of 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specificity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy | Specificity is the ability of a test to correctly determine the absence of disease (true negative). This study determined how accurately F18 NaF PET/CT performed at detecting the absence of disease. The calculation for specificity is TN / (TN + FP), where: TN = the participant was a true negative (the lesion was not detected on F18 NaF PET/CT and the patient does not have the disease) FP = the participant was a false positive (the lesion was falsely detected on the F18 NaF PET/CT and the patient does not have the disease) The result is expressed as a percentage. | an estimated average of 2 hours | 
| Sensitivity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy | Sensitivity is the ability of a test to correctly identify those with the disease (true positive rate). This study determined how many lesions were detected by F18 NaF PET/CT compared to the known results. The calculation for sensitivity is TP / (TP+FN), where: TP = true positive (the lesion was accurately detected on both F18 NaF and comparison study) FN = false negative (the lesion was not detected on the PET/CT but was detected on the comparison study) The result is expressed as the percentage of confirmed lesions across all participants that were also detected by F18 NaF PET/CT. | an estimated average of 2 hours |