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Combined F-18 NaF and F-18 FDG PET/CT for Evaluation of Malignancy

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: NCT00725387
Recruitment Status : Completed
First Posted : July 30, 2008
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Description
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Brief Summary:
Fluorine-18 Fluorodeoxyglucose (F-18 FDG) PET/CT is established as a powerful imaging tool for cancer detection and monitoring response to therapy. Sodium Fluorine-18 (F-18) was used in the 1970s for bone scanning and can be used as a skeletal tracer in current PET/CT scanners. The combined administration of F-18 and F-18 FDG in a single PET/CT scan for cancer detection was not attempted to date. We hope to learn what is the best approach for detection of cancer and thus to improve cancer treatment.

Condition or disease
Neoplasms

Study Design
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Study Type : Observational
Actual Enrollment : 214 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Combined F-18 NaF and F-18 FDG PET/CT for Evaluation of Malignancy
Actual Study Start Date : August 2007
Actual Primary Completion Date : December 2018
Actual Study Completion Date : June 2019
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Percent of patients with evidence of new lesions on combined F-18/F-18 FDG PET/CT. [ Time Frame: not defined ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients must be referred for evaluation of bone metastases.
Criteria

Inclusion Criteria:

  • Patients older than 18-year-old, diagnosed with 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
  • Patients participating in other research studies

The subjects will not be paid to participate in this protocol. No costs will be charged to the subjects.

Contacts and Locations
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Information from the National Library of Medicine

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): NCT00725387


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Denmark
Aalborg Hospital
Aalborg, Denmark
India
Apollo Hospital
Chennai, India
Portugal
Coimbra University Hospital
Coimbra, Portugal
South Africa
Pretoria Academic Hospital
Pretoria, South Africa
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Andrei Iagaru M.D Stanford University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00725387    
Other Study ID Numbers: VAR0024
98043 ( Other Identifier: Stanford University Alternate IRB Approval No. )
SU-07232008-1266 ( Other Identifier: Stanford University )
First Posted: July 30, 2008    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neoplasms