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

• ClinicalTrials.gov Identifier: NCT00725387
• Recruitment Status: Completed
• First Posted: July 30, 2008
• Last Update Posted: September 18, 2019
• Sponsor: Stanford University
• 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
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 19, 2018): 214
• Original Enrollment (submitted: July 28, 2008): 100
• 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.

Sex/Gender

• 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

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

Investigators

• Principal Investigator: Andrei Iagaru M.D; Stanford University

• PRS Account: Stanford University
• Verification Date: September 2019