Combined F18 and F18 FDG PET/CT for Evaluation of Malignancy
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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 |
- 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 |
Patients must be referred for evaluation of bone metastases.
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| Contact: Euodia Jonathan | 650 723 7419 | euodia@stanford.edu |
| Contact: Lindee Burton | 650 725 4712 | lburton@stanford.edu |
| 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 | |
| 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: | December 11, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013