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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00725387
First received: July 28, 2008
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


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 2015
Estimated Primary Completion Date: December 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00725387

Contacts
Contact: Elizabeth Chitouras 650-498-0623 echitouras@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Elizabeth Chitouras    650-498-0623    echitouras@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: Andrei Iagaru M.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: July 21, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 21, 2014