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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00725387
Recruitment Status : Recruiting
First Posted : July 30, 2008
Last Update Posted : April 23, 2018
Information provided by (Responsible Party):
Stanford University

July 28, 2008
July 30, 2008
April 23, 2018
August 2007
December 2018   (Final data collection date for primary outcome measure)
Percent of patients with evidence of new lesions on combined F-18/F-18 FDG PET/CT. [ Time Frame: not defined ]
Testing the hypothesis that the adjunctive combination of the F-18 FDG in a single PET/CT scan is feasible
Complete list of historical versions of study NCT00725387 on Archive Site
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  • Evaluating F-18 and F-18 FDG single PET/CT scan vs F-18 PET/CT and F-18 FDG perfpormed separately
  • Evaluating imaging protocols performance and reliability.
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Combined F-18 NaF and F-18 FDG PET/CT for Evaluation of Malignancy
Combined F-18 NaF and F-18 FDG PET/CT for Evaluation of Malignancy
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.
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Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Patients must be referred for evaluation of bone metastases.
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Iagaru A, Mittra E, Mosci C, Dick DW, Sathekge M, Prakash V, Iyer V, Lapa P, Isidoro J, de Lima JM, Gambhir SS. Combined 18F-fluoride and 18F-FDG PET/CT scanning for evaluation of malignancy: results of an international multicenter trial. J Nucl Med. 2013 Feb;54(2):176-83. doi: 10.2967/jnumed.112.108803. Epub 2012 Dec 14.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2018
December 2018   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Denmark,   India,   Portugal,   South Africa,   United States
98043 ( Other Identifier: Stanford University Alternate IRB Approval No. )
SU-07232008-1266 ( Other Identifier: Stanford University )
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Stanford University
Stanford University
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Principal Investigator: Andrei Iagaru M.D Stanford University
Stanford University
April 2018