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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
Information provided by (Responsible Party):
Stanford University

Tracking Information
First Submitted Date July 28, 2008
First Posted Date July 30, 2008
Last Update Posted Date September 18, 2019
Actual Study Start Date August 2007
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 11, 2012)
Percent of patients with evidence of new lesions on combined F-18/F-18 FDG PET/CT. [ Time Frame: not defined ]
Original Primary Outcome Measures
 (submitted: July 28, 2008)
Testing the hypothesis that the adjunctive combination of the F-18 FDG in a single PET/CT scan is feasible
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: July 28, 2008)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Combined F-18 NaF and F-18 FDG PET/CT for Evaluation of Malignancy
Official Title Combined F-18 NaF and F-18 FDG PET/CT for Evaluation of Malignancy
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients must be referred for evaluation of bone metastases.
Condition Neoplasms
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 19, 2018)
Original Enrollment
 (submitted: July 28, 2008)
Actual Study Completion Date June 2019
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility 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.

Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark,   India,   Portugal,   South Africa,   United States
Removed Location Countries  
Administrative Information
NCT Number NCT00725387
Other Study ID Numbers VAR0024
98043 ( Other Identifier: Stanford University Alternate IRB Approval No. )
SU-07232008-1266 ( Other Identifier: Stanford University )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Stanford University
Original Responsible Party Not Provided
Current Study Sponsor Stanford University
Original Study Sponsor Same as current
Collaborators Not Provided
Principal Investigator: Andrei Iagaru M.D Stanford University
PRS Account Stanford University
Verification Date September 2019