Last updated on November 2012

F18PET/CT Versus TC-MDP Scanning to Detect Bone Mets


Brief description of study

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.

Detailed Study Description

The trial will accrue four hundred-eighty eight (488) evaluable patients with breast cancer, prostate cancer or lung cancer (approximately 163 of each cancer type) referred for routine bone scanning by their respective physicians. The specific stages of cancer required for eligibility are described in the eligibility criteria. Approximately eleven to fifteen qualified clinical centers will participate in the trial, with target enrollment for each site set at roughly 40-50 patients per site. The images of the patients will be transmitted to ACR Image Metrix, an imaging contract research organization (iCRO), for quality assurance and archival. iCRO will conduct blinded core lab interpretations by 3 radiologists who have not been involved in the design of the trial nor the clinical image interpretation. The data from the core lab readings will be compared with the deliberations of a multidisciplinary panel of oncology experts who will be blinded to the initial scan results and will determine the standard of evidence (truth) for each patient. The analysis will be based on this comparison.

Clinical Study Identifier: NCT00882609

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Ronald Korn, MD

Scottsdale Medical Imaging
Scottsdale, AZ United States
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Johannes Czernin, MD

Silicon Valley Imaging
Freemont, CA United States
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Johannes Czernin, MD

Cedar-Sinai Medical Center
Los Angeles, CA United States
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Martin Auerbach, MD

UCLA
Los Angeles, CA United States
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Gholam Berenji, MD

VA West Los Angles Medical Center
Los Angeles, CA United States
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Samjiv Gambhir, MD

Stanford University Medical Center
Stanford, CA United States
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Patricia Shapiro, MD

SouthCoast Imaging Center
Savannah, GA United States
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Morand Piert, MD

University of Michigan Health System
Ann Arbor, MI United States
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Pablo Delgado, MD

Saint Luke's Hospital
Kansas City, MO United States
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Medhat Osman, MD

John Cochran Veterans Administration
Saint Louis, MO United States
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Medhat Osman, MD

Saint Louis University
Saint Louis, MO United States
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Seltzer Marc, MD

Dartmouth-Hitchcock Medical Center
Lebanon, NH United States
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Pablo Delgado, MD

New York Presbyterian Weill Cornell
New York, NY United States
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Homer Macapinlac, MD

University of Texas MD Anderson Cancer Center
Houston, TX United States
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John Hoffman

University of Utah School of Medicine
Salt Lake, UT United States
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Michael Hofman, MD

Peter MacCallum
Melbourne, Australia
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Werner Langsteger, MD

PET-CT Linz - St. Vicent's Hospital
Linz, Austria
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Joao de Lima, MD

Hospitais da Universidade de Coimbra
Coimbra, Portugal
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Johannes Czernin, MD

University Hospital Zurich
Zurich, Switzerland
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