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: December 10, 2013
Last verified: December 2013
  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:


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.


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
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
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

No publications provided

Responsible Party: Andrew Quon, Associate Professor of Radiology, 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: December 10, 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
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014