Back to resultsSodium Fluoride PET/CT for the Evaluation of Skeletal Cancer
Primary Purpose
Bone Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fluorine F 18 sodium fluoride
positron emission tomography/computed tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Bone Cancer
Eligibility Criteria
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
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (fluorine F 18 sodium fluoride PET/CT)
Arm Description
Patients undergo fluorine F 18 sodium fluoride PET/CT scan.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01541358
Brief Title
Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer
Official Title
Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Low accrual and no funding
Study Start Date
May 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (fluorine F 18 sodium fluoride PET/CT)
Arm Type
Experimental
Arm Description
Patients undergo fluorine F 18 sodium fluoride PET/CT scan.
Intervention Type
Radiation
Intervention Name(s)
fluorine F 18 sodium fluoride
Other Intervention Name(s)
18 F-NaF, F-18 NaF
Intervention Description
Undergo fluorine F 18 sodium fluoride PET/CT scan
Intervention Type
Procedure
Intervention Name(s)
positron emission tomography/computed tomography
Intervention Description
Undergo fluorine F 18 sodium fluoride PET/CT scan
Primary Outcome Measure Information:
Title
Total Number of Lesions Identified by F-18 NaF PET/CT in Patients With Suspected Skeletal Malignancy
Description
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
Secondary Outcome Measure Information:
Title
Specificity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy
Description
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
Title
Sensitivity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Quon
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer
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