Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer
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| ClinicalTrials.gov Identifier: NCT01541358 |
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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
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bone Cancer | Radiation: fluorine F 18 sodium fluoride Procedure: positron emission tomography/computed tomography | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer |
| Study Start Date : | May 2012 |
| Actual Primary Completion Date : | September 2012 |
| Actual Study Completion Date : | September 2012 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Diagnostic (fluorine F 18 sodium fluoride PET/CT)
Patients undergo fluorine F 18 sodium fluoride PET/CT scan.
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Radiation: fluorine F 18 sodium fluoride
Undergo fluorine F 18 sodium fluoride PET/CT scan
Other Names:
Procedure: positron emission tomography/computed tomography Undergo fluorine F 18 sodium fluoride PET/CT scan |
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01541358
| United States, California | |
| Stanford University | |
| Stanford, California, United States, 94305 | |
| Principal Investigator: | Andrew Quon | Stanford University |
| 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 ) |
| First Posted: | February 29, 2012 Key Record Dates |
| Results First Posted: | June 14, 2017 |
| Last Update Posted: | June 14, 2017 |
| Last Verified: | May 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
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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 |