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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00138 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| SU-02162012-9128 | Other Identifier | Stanford University | |
| VAR0074 | Other Identifier | OnCore |
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Low accrual and no funding
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (fluorine F 18 sodium fluoride PET/CT) | Experimental | Patients undergo fluorine F 18 sodium fluoride PET/CT scan. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluorine F 18 sodium fluoride | Radiation | Undergo fluorine F 18 sodium fluoride PET/CT scan |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Quon | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT) | Patients were injected with approximately 5mCi F18 NaF and undergo a PET/CT scan approximately 60 minutes later. A whole body non-contrast CT was obtained for attenuation correction and anatomic localization of radiotracer activity. Positron emission tomographic scans were obtained over the same anatomical regions as the CT scan. Images were reconstructed and reviewed in the axial, coronal, and sagittal planes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Includes all study participants. | Posted | Number | lesions detected by F18 NaF | an estimated average of 2 hours |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT) | Patients undergo fluorine F 18 sodium fluoride PET/CT scan. fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET/CT scan positron emission tomography/computed tomography: Undergo fluorine F 18 sodium fluoride PET/CT scan |
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Low participant enrollment. The uptake of fluoride ions is better in bone remodeling processes, while purely bone lytic processes have a lower uptake, or no uptake at all, which is a limitation of F-18 NaF PET/CT bone scan.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Quon, MD | David Geffen School of Medicine at UCLA | 310-983-1419 | AQuon@mednet.ucla.edu |
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| ID | Term |
|---|---|
| D001859 | Bone Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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| positron emission tomography/computed tomography | Procedure | Undergo fluorine F 18 sodium fluoride PET/CT scan |
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| 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 |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | 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. | Both participants were included in the analysis. | Posted | Number | percentage of specificity | an estimated average of 2 hours |
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| Secondary | 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. | Both participants were included in the analysis. | Posted | Number | percentage of sensitivity | an estimated average of 2 hours |
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