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NCT01541358 Clinical Trial

Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer

Bone Cancer Clinical Trial

Official title:
Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01541358
Other study ID # VAR0074
Secondary ID NCI-2012-00138SU
Status Terminated
Phase N/A
First received February 23, 2012
Last updated December 10, 2013
Start date May 2012
Est. completion date September 2012

Study information
Verified date December 2013
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Stanford University Stanford California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of lesions with fluorine F 18 sodium fluoride PET/CT in patients who have suspected skeletal malignancy Imaging will take approximately two hours in total. 2 hours No
Primary Sensitivity of skeletal lesions with fluorine F 18 sodium fluoride PET/CT in patients with suspected skeletal malignancy Imaging will take approximately two hours in total. 2 hours No
Primary Specificity of skeletal lesions with fluorine F 18 sodium fluoride PET/CT in patients with suspected skeletal malignancy Imaging will take approximately two hours in total. 2 hours No
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