Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
550 participants
INTERVENTIONAL
2009-01-31
2013-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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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
Bone Scan: F18-Fluoride PET/CT or TC-MDP
Each patient will be randomized into one of two groups with one group receiving Sodium Fluoride F18 Injection and the other receiving the control agent, 99mTc-MDPSodium Fluoride F18 Injection Dosing and Administration. The dose will be tailored for the specific patient for whom the dose was ordered. The dose of Sodium Fluoride F18 Injection administered will range from 5-10 mCi/patient.Each patient randomized to the control group will be administered 99mTc-MDP as a single intravenous bolus dose. The administered radioactivity will be determined based on the sites routine clinical practice for conventional bone imaging.
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
Bone Scan: F18-Fluoride PET/CT or TC-MDP
Each patient will be randomized into one of two groups with one group receiving Sodium Fluoride F18 Injection and the other receiving the control agent, 99mTc-MDPSodium Fluoride F18 Injection Dosing and Administration. The dose will be tailored for the specific patient for whom the dose was ordered. The dose of Sodium Fluoride F18 Injection administered will range from 5-10 mCi/patient.Each patient randomized to the control group will be administered 99mTc-MDP as a single intravenous bolus dose. The administered radioactivity will be determined based on the sites routine clinical practice for conventional bone imaging.
Interventions
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Bone Scan: F18-Fluoride PET/CT or TC-MDP
Each patient will be randomized into one of two groups with one group receiving Sodium Fluoride F18 Injection and the other receiving the control agent, 99mTc-MDPSodium Fluoride F18 Injection Dosing and Administration. The dose will be tailored for the specific patient for whom the dose was ordered. The dose of Sodium Fluoride F18 Injection administered will range from 5-10 mCi/patient.Each patient randomized to the control group will be administered 99mTc-MDP as a single intravenous bolus dose. The administered radioactivity will be determined based on the sites routine clinical practice for conventional bone imaging.
Eligibility Criteria
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Inclusion Criteria
* Patient or patient's legally acceptable representative cognitively provides written informed consent
* 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
* Patient is capable of complying with study procedures
* Patient is able to remain still for duration of imaging procedure (about one hour)
* Patient may have had a prior PET or PET/CT scan for staging/restaging.
Exclusion Criteria
* Patient is pregnant or nursing;
* testing on site at the institution (urine or serum ßHCG) within 24 hours prior to the start of investigational product administration
* obtaining surgical history (e.g., tubal ligation or hysterectomy)
* confirming the subject is post menopausal, with a minimum 1 year without menses
* Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data
* Patient has known bone metastases
* Patient has previously received \[18F\]NaF in the last thirty days
18 Years
ALL
No
Sponsors
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World Molecular Imaging Society
UNKNOWN
American College of Radiology - Image Metrix
INDUSTRY
Responsible Party
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Principal Investigators
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Johannes Czernin, MD
Role: PRINCIPAL_INVESTIGATOR
World Molecular Imaging Society
Locations
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Scottsdale Medical Imaging
Scottsdale, Arizona, United States
Silicon Valley Imaging
Freemont, California, United States
Cedar-Sinai Medical Center
Los Angeles, California, United States
VA West Los Angles Medical Center
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
Stanford University Medical Center
Stanford, California, United States
SouthCoast Imaging Center
Savannah, Georgia, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Saint Luke's Hospital
Kansas City, Missouri, United States
John Cochran Veterans Administration
St Louis, Missouri, United States
Saint Louis University
St Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
New York Presbyterian Weill Cornell
New York, New York, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Utah School of Medicine
Salt Lake City, Utah, United States
Peter MacCallum
Melbourne, Victoria, Australia
PET-CT Linz - St. Vicent's Hospital
Linz, Linz, Austria
Hospitais da Universidade de Coimbra
Coimbra, Portugal, Portugal
University Hospital Zurich
Zurich, Switzerland, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Jocelyn Harmon
Role: primary
Gholam Berenji, MD
Role: primary
Martin A Auerbach, MD
Role: primary
Lindee Burton
Role: primary
Nicole Couturier
Role: primary
Kristine Wernette
Role: primary
Trent West
Role: primary
Ryan Warhoover
Role: primary
Martha Edwards
Role: primary
Suzanne Lenz
Role: primary
Ame Ng
Role: primary
Louis Kidd
Role: primary
Britney Beardmore
Role: primary
Regan Butterfield
Role: backup
Elizabeth Drummond
Role: primary
Mohsen Beheshti, MD
Role: primary
Paula Lapa, MD
Role: primary
Other Identifiers
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AMI-2008-01
Identifier Type: -
Identifier Source: org_study_id