Combined F18 and F18 FDG PET/CT for Evaluation of Malignancy

This study is currently recruiting participants.
Verified October 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00725387
First received: July 28, 2008
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

Fluorine-18 Fluorodeoxyglucose (F-18 FDG) PET/CT is established as a powerful imaging tool for cancer detection and monitoring response to therapy. However, not all cancers are identified reliably due to variable rates of glucose metabolism. 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. However, such an approach has the potential to improve cancer diagnosis, staging, prognosis, and therapy monitoring. The combination of these technologies may also allow for shorter imaging times, lower costs, as well as improved screening or earlier cancer detection. The investigators will attempt a pilot study with 10 patients to acquire the preliminary results needed to proceed with additional 90 subjects.


Condition
Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Combined F18 and F18 FDG PET/CT for Evaluation of Malignancy

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: August 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00725387

Contacts
Contact: Euodia Jonathan 650 723 7419 euodia@stanford.edu
Contact: Lindee Burton 650 725 4712 lburton@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Euodia Jonathan    650-723-7419    euodia@stanford.edu   
Contact: Cancer Clinical Trials Office    (650) 498-7061      
Principal Investigator: Sanjiv Sam Gambhir M.D., Ph.D.         
Sub-Investigator: Andrei Iagaru, MD         
Denmark
Aalborg Hospital Recruiting
Aalborg, Denmark
Contact: Andrei Iagaru    (650) 736-2859    aiagaru@stanford.edu   
Principal Investigator: Vineet Prakash, MD         
India
Apollo Hospital Recruiting
Chennai, India
Contact: Andrei Iagaru    650-736-2859    aiagaru@stanford.edu   
Principal Investigator: Jyotsna Rao, MD         
Portugal
Coimbra University Hospital Recruiting
Coimbra, Portugal
Contact: Andrei Iagaru    650-736-2859    aiagaru@stanford.edu   
Principal Investigator: Jo Manuel Pedroso de Lima, MD         
South Africa
Pretoria Academic Hospital Recruiting
Pretoria, South Africa
Contact: Andrei Iagaru    650-736-2859    aiagaru@stanford.edu   
Principal Investigator: Mike Sathekge, MD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Sanjiv Sam Gambhir M.D., Ph.D. Stanford University
  More Information

No publications provided by Stanford University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00725387     History of Changes
Other Study ID Numbers: VAR0024, 98043, SU-07232008-1266
Study First Received: July 28, 2008
Last Updated: October 28, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 23, 2014