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Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer

This study is currently recruiting participants.
Verified January 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01541358
First received: February 23, 2012
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Number of lesions with fluorine F 18 sodium fluoride PET/CT in patients who have suspected skeletal malignancy [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Imaging will take approximately two hours in total.


Estimated Enrollment: 20
Study Start Date: May 2012
Estimated Primary Completion Date: May 2014 (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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541358

Contacts
Contact: Euodia Jonathan 650-723-7419 euodia@stanford.edu
Contact: Cancer Clinical Trials Office 650-498-7061

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Andrew Quon     650-736-1369     aquon@stanford.edu    
Principal Investigator: Andrew Quon            
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Andrew Quon Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01541358     History of Changes
Other Study ID Numbers: VAR0074, NCI-2012-00138, SU-02162012-9128, 23082
Study First Received: February 23, 2012
Last Updated: January 18, 2013
Health Authority: United States: Food and Drug Administration

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
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013