Bone Cancer
Conditions
Brief summary
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
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.
Interventions
RADIATIONfluorine F 18 sodium fluoride
Undergo fluorine F 18 sodium fluoride PET/CT scan
Undergo fluorine F 18 sodium fluoride PET/CT scan
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Lesions Identified by F-18 NaF PET/CT in Patients With Suspected Skeletal Malignancy | an estimated average of 2 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specificity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy | an estimated average of 2 hours | 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. |
| Sensitivity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy | an estimated average of 2 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT) | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
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.
Time frame: an estimated average of 2 hours
Population: Includes all study participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT) | Total Number of Lesions Identified by F-18 NaF PET/CT in Patients With Suspected Skeletal Malignancy | 1 lesions detected by F18 NaF |
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.
Time frame: an estimated average of 2 hours
Population: Both participants were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT) | Sensitivity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy | 14 percentage of sensitivity |
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.
Time frame: an estimated average of 2 hours
Population: Both participants were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT) | Specificity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy | 100 percentage of specificity |