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Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer

This study has been terminated.
(Low accrual and no funding)
Sponsor:
Information provided by (Responsible Party):
Andrew Quon, Stanford University
ClinicalTrials.gov Identifier:
NCT01541358
First received: February 23, 2012
Last updated: May 12, 2017
Last verified: May 2017
  Purpose
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

Condition Intervention
Bone Cancer Radiation: fluorine F 18 sodium fluoride Procedure: positron emission tomography/computed tomography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer

Resource links provided by NLM:


Further study details as provided by Andrew Quon, Stanford University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Enrollment: 2
Study Start Date: May 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (fluorine F 18 sodium fluoride PET/CT)
Patients undergo fluorine F 18 sodium fluoride PET/CT scan.
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541358

Locations
United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Andrew Quon Stanford University
  More Information

Responsible Party: Andrew Quon, Associate Professor of Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT01541358     History of Changes
Other Study ID Numbers: IRB-23082
NCI-2012-00138 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SU-02162012-9128 ( Other Identifier: Stanford University )
VAR0074 ( Other Identifier: OnCore )
Study First Received: February 23, 2012
Results First Received: February 14, 2017
Last Updated: May 12, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Bone Neoplasms
Osteosarcoma
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Sarcoma
Fluorides
Sodium Fluoride
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents

ClinicalTrials.gov processed this record on June 28, 2017