Trial Outcomes & Findings for Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer (NCT NCT01541358)

Last Updated: 2017-06-14

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

an estimated average of 2 hours

Results posted on

2017-06-14

Participant Flow

Participant milestones

Participant milestones
Measure	Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT) 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 Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT) n=2 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: an estimated average of 2 hours

Population: Includes all study participants.

Outcome measures

Outcome measures
Measure	Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT) n=2 Participants 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.
Total Number of Lesions Identified by F-18 NaF PET/CT in Patients With Suspected Skeletal Malignancy	1 lesions detected by F18 NaF

SECONDARY outcome

Timeframe: an estimated average of 2 hours

Population: Both participants were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT) n=2 Participants 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.
Specificity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy	100 percentage of specificity

SECONDARY outcome

Timeframe: an estimated average of 2 hours

Population: Both participants were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT) n=2 Participants 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.
Sensitivity of F-18 NaF PET/CT to Detect Bone Lesions in Patients With Suspected Skeletal Malignancy	14 percentage of sensitivity

Adverse Events

Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrew Quon, MD

David Geffen School of Medicine at UCLA

Phone: 310-983-1419

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place