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Sponsors and Collaborators: |
American College of Radiology - Image Metrix Academy of Molecular Imaging |
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Information provided by: | American College of Radiology - Image Metrix |
ClinicalTrials.gov Identifier: | NCT00882609 |
The primary objective is to compare the diagnostic performance of 18F- Fluoride PET/CT scanning to that of conventional bone scanning for detecting cancer that has spread to the bone (bone metastasis). The intent of the study is to determine whether 18F-Fluoride PET/CT will lead to improved treatment and patient outcomes.
Condition |
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Bone Metastases |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | 18F-Fluoride PET/CT Versus 99mTc-MDP Scanning for Detecting Bone Metastases: A Randomized, Multi-Center Trial to Compare Two Bone Imaging Techniques |
Estimated Enrollment: | 550 |
Study Start Date: | January 2009 |
Groups/Cohorts |
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TC-MDP Bone Scan
Patients without known bone metastases who are newly diagnosed with ≥ stage 3 breast cancer, ≥ stage 3 lung cancer, or ≥ stage 2 prostate cancer (and/or PSA >10 micrograms/L), including patient with recurrent breast, lung or prostate cancer; Patient is scheduled to undergo a conventional bone scan
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F18-Fluoride PET/CT
Patients without known bone metastases who are newly diagnosed with ≥ stage 3 breast cancer, ≥ stage 3 lung cancer, or ≥ stage 2 prostate cancer (and/or PSA >10 micrograms/L), including patient with recurrent breast, lung or prostate cancer; Patient is scheduled to undergo a conventional bone scan
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Patients without known bone metastases who are newly diagnosed with ≥ stage 3 breast cancer, ≥ stage 3 lung cancer, or ≥ stage 2 prostate cancer (and/or PSA >10 micrograms/L), including patient with recurrent breast, lung or prostate cancer; Patient is scheduled to undergo a conventional bone scan
Inclusion Criteria:
Exclusion Criteria:
Patient is pregnant or nursing;
Contact: Johannes Czernin, MD | (310) 206-3226 | JCzernin@mednet.ucla.edu |
United States, Arizona | |
Scottsdale Medical Imaging | Recruiting |
Scottsdale, Arizona, United States, 85252 | |
Contact: Maya Hernandez 480-425-4191 mhern@esmil.com | |
Principal Investigator: Ronald Korn, MD | |
United States, California | |
UCLA | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Martin A Auerbach, MD 310-983-1444 mauerbach@mednet.ucla.net | |
Principal Investigator: Martin Auerbach, MD |
Responsible Party: | Academy of Molecular Imaging ( Johannes Czernin, MD ) |
Study ID Numbers: | AMI-2008-01 |
Study First Received: | April 15, 2009 |
Last Updated: | April 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00882609 History of Changes |
Health Authority: | United States: Food and Drug Administration |
bone metastasis bone metastases Sodium Fluoride F18 Fluoride |
Musculoskeletal Diseases Bone Neoplasms Hematologic Diseases Neoplasm Metastasis |
Fluorides Bone Marrow Diseases Bone Diseases |
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Musculoskeletal Diseases |
Bone Neoplasms Hematologic Diseases Neoplasm Metastasis Bone Marrow Diseases Bone Diseases |