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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00725387
First received: July 28, 2008
Last updated: September 21, 2016
Last verified: September 2016

July 28, 2008
September 21, 2016
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 ] [ Designated as safety issue: No ]
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 ClinicalTrials.gov 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
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Patients must be referred for evaluation of bone metastases.
Neoplasms
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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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
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.

Both
18 Years and older   (Adult, Senior)
No
United States,   Denmark,   India,   Portugal,   South Africa
 
NCT00725387
VAR0024, 98043, SU-07232008-1266
Yes
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Stanford University
Stanford University
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Principal Investigator: Andrei Iagaru M.D Stanford University
Stanford University
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP