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Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer

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ClinicalTrials.gov Identifier: NCT01541358
Recruitment Status : Terminated (Low accrual and no funding)
First Posted : February 29, 2012
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Andrew Quon, Stanford University

Tracking Information
First Submitted Date  ICMJE February 23, 2012
First Posted Date  ICMJE February 29, 2012
Results First Submitted Date  ICMJE February 14, 2017
Results First Posted Date  ICMJE June 14, 2017
Last Update Posted Date June 14, 2017
Study Start Date  ICMJE May 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2017)
Total Number of Lesions Identified by F-18 NaF PET/CT in Patients With Suspected Skeletal Malignancy [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 23, 2012)
  • Number of lesions with fluorine F 18 sodium fluoride PET/CT in patients who have suspected skeletal malignancy [ Time Frame: 2 hours ]
    Imaging will take approximately two hours in total.
  • Sensitivity of skeletal lesions with fluorine F 18 sodium fluoride PET/CT in patients with suspected skeletal malignancy [ Time Frame: 2 hours ]
    Imaging will take approximately two hours in total.
  • Specificity of skeletal lesions with fluorine F 18 sodium fluoride PET/CT in patients with suspected skeletal malignancy [ Time Frame: 2 hours ]
    Imaging will take approximately two hours in total.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2017)
  • Specificity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer
Official Title  ICMJE Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Bone Cancer
Intervention  ICMJE
  • Radiation: fluorine F 18 sodium fluoride
    Undergo fluorine F 18 sodium fluoride PET/CT scan
    Other Names:
    • 18 F-NaF
    • F-18 NaF
  • Procedure: positron emission tomography/computed tomography
    Undergo fluorine F 18 sodium fluoride PET/CT scan
Study Arms  ICMJE Experimental: Diagnostic (fluorine F 18 sodium fluoride PET/CT)
Patients undergo fluorine F 18 sodium fluoride PET/CT scan.
Interventions:
  • Radiation: fluorine F 18 sodium fluoride
  • Procedure: positron emission tomography/computed tomography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 5, 2013)
2
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2012)
20
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01541358
Other Study ID Numbers  ICMJE IRB-23082
NCI-2012-00138 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SU-02162012-9128 ( Other Identifier: Stanford University )
VAR0074 ( Other Identifier: OnCore )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Andrew Quon, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew Quon Stanford University
PRS Account Stanford University
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP