Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer - Full Text View

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:

MedlinePlus related topics: Bone Cancer CT Scans

Drug Information available for: Sodium fluoride Fluorine Fluoride Listerine

Genetic and Rare Diseases Information Center resources: Osteosarcoma Soft Tissue Sarcoma

U.S. FDA Resources

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 (IPD) Sharing Statement:
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 July 21, 2017