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Trial record 8 of 292 for:    Sodium Fluoride OR Duraphat

Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Bone Cancer
Interventions Radiation: fluorine F 18 sodium fluoride
Procedure: positron emission tomography/computed tomography
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)
Hide Arm/Group Description

Patients were injected with approximately 5mCi F18 NaF and undergo a PET/CT scan approximately 60 minutes later.

A whole body non-contrast CT was obtained for attenuation correction and anatomic localization of radiotracer activity. Positron emission tomographic scans were obtained over the same anatomical regions as the CT scan. Images were reconstructed and reviewed in the axial, coronal, and sagittal planes.

Period Title: Overall Study
Started 2
Completed 2
Not Completed 0
Arm/Group Title Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
2
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
1
  50.0%
Male
1
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
0
   0.0%
Unknown or Not Reported
2
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
2
 100.0%
1.Primary Outcome
Title Total Number of Lesions Identified by F-18 NaF PET/CT in Patients With Suspected Skeletal Malignancy
Hide Description 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.
Time Frame an estimated average of 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all study participants.
Arm/Group Title Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)
Hide Arm/Group Description:

Patients were injected with approximately 5mCi F18 NaF and underwent a PET/CT scan approximately 60 minutes later.

A whole body non-contrast CT was obtained for attenuation correction and anatomic localization of radiotracer activity. Positron emission tomographic scans were obtained over the same anatomical regions as the CT scan. Images were reconstructed and reviewed in the axial, coronal, and sagittal planes.

Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: lesions detected by F18 NaF
1
2.Secondary Outcome
Title Specificity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy
Hide Description

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.

Time Frame an estimated average of 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Both participants were included in the analysis.
Arm/Group Title Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)
Hide Arm/Group Description:

Patients were injected with approximately 5mCi F18 NaF and undergo a PET/CT scan approximately 60 minutes later.

A whole body non-contrast CT was obtained for attenuation correction and anatomic localization of radiotracer activity. Positron emission tomographic scans were obtained over the same anatomical regions as the CT scan. Images were reconstructed and reviewed in the axial, coronal, and sagittal planes.

Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: percentage of specificity
100
3.Secondary Outcome
Title Sensitivity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy
Hide Description

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.

Time Frame an estimated average of 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Both participants were included in the analysis.
Arm/Group Title Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)
Hide Arm/Group Description:

Patients were injected with approximately 5mCi F18 NaF and underwent a PET/CT scan approximately 60 minutes later.

A whole body non-contrast CT was obtained for attenuation correction and anatomic localization of radiotracer activity. Positron emission tomographic scans were obtained over the same anatomical regions as the CT scan. Images were reconstructed and reviewed in the axial, coronal, and sagittal planes.

Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: percentage of sensitivity
14
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)
Hide Arm/Group Description

Patients undergo fluorine F 18 sodium fluoride PET/CT scan.

fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET/CT scan

positron emission tomography/computed tomography: Undergo fluorine F 18 sodium fluoride PET/CT scan

All-Cause Mortality
Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)
Affected / at Risk (%)
Total   0/2 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)
Affected / at Risk (%)
Total   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)
Affected / at Risk (%)
Total   0/2 (0.00%) 
Low participant enrollment. The uptake of fluoride ions is better in bone remodeling processes, while purely bone lytic processes have a lower uptake, or no uptake at all, which is a limitation of F-18 NaF PET/CT bone scan.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andrew Quon, MD
Organization: David Geffen School of Medicine at UCLA
Phone: 310-983-1419
EMail: AQuon@mednet.ucla.edu
Layout table for additonal information
Responsible Party: Andrew Quon, 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 )
First Submitted: February 23, 2012
First Posted: February 29, 2012
Results First Submitted: February 14, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017