Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer
This study has been terminated.
(Low accrual and no funding)
Sponsor:
Stanford University
Information provided by (Responsible Party):
Andrew Quon, Stanford University
ClinicalTrials.gov Identifier:
NCT01541358
First received: February 23, 2012
Last updated: December 10, 2013
Last verified: December 2013
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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: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Bone Cancer
Osteosarcoma
Malignant Mesenchymal Tumor
Soft Tissue Sarcoma
U.S. FDA Resources
Further study details as provided by Stanford University:
Primary Outcome Measures:
- Number of lesions with fluorine F 18 sodium fluoride PET/CT in patients who have suspected skeletal malignancy [ Time Frame: 2 hours ] [ Designated as safety issue: No ]Imaging will take approximately two hours in total.
- Sensitivity of skeletal lesions with fluorine F 18 sodium fluoride PET/CT in patients with suspected skeletal malignancy [ Time Frame: 2 hours ] [ Designated as safety issue: No ]Imaging will take approximately two hours in total.
- Specificity of skeletal lesions with fluorine F 18 sodium fluoride PET/CT in patients with suspected skeletal malignancy [ Time Frame: 2 hours ] [ Designated as safety issue: No ]Imaging will take approximately two hours in total.
| 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:
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) |
| Genders Eligible for Study: | Both |
| 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
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: | VAR0074 NCI-2012-00138 SU-02162012-9128 23082 |
| Study First Received: | February 23, 2012 |
| Last Updated: | December 10, 2013 |
| Health Authority: | United States: Food and Drug Administration |
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 September 23, 2016