Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by American College of Radiology - Image Metrix.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
World Molecular Imaging Society
Information provided by (Responsible Party):
American College of Radiology - Image Metrix
ClinicalTrials.gov Identifier:
NCT00882609
First received: April 15, 2009
Last updated: November 28, 2012
Last verified: November 2012
  Purpose
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 Intervention Phase
Bone Metastases
Device: Bone Scan: F18-Fluoride PET/CT or TC-MDP
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by American College of Radiology - Image Metrix:

Primary Outcome Measures:
  • Analysis of the diagnostic performance of [18F]NaF fluoride PET/CT scanning [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    The primary endpoint will be an analysis of the diagnostic performance of [18F]NaF fluoride PET/CT scanning to that of conventional bone scanning for detecting cancer that has spread to the bone (bone metastasis). The hypothesis is that PET/CT is superior to conventional bone scanning for detecting bone metastases. The primary metrics used for comparison will be the relative areas under the ROC curves generated by blinded core lab interpretations of the scans.


Estimated Enrollment: 550
Study Start Date: January 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
Device: 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.
Experimental: 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
Device: 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is ≥ 18 years old at the time of the drug administration (Patient may be male or female of any race / ethnicity.)
  • 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 < 18 years old at the time of the drug administration
  • 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
  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: NCT00882609

Locations
United States, Arizona
Scottsdale Medical Imaging
Scottsdale, Arizona, United States, 85252
United States, California
Silicon Valley Imaging
Freemont, California, United States, 94538
Cedar-Sinai Medical Center
Los Angeles, California, United States, 90048
VA West Los Angles Medical Center
Los Angeles, California, United States, 90073
UCLA
Los Angeles, California, United States, 90095
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Georgia
SouthCoast Imaging Center
Savannah, Georgia, United States, 31406
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
John Cochran Veterans Administration
Saint Louis, Missouri, United States, 63106
Saint Louis University
Saint Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
New York Presbyterian Weill Cornell
New York, New York, United States, 10065
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
University of Utah School of Medicine
Salt Lake, Utah, United States, 84112
Australia, Victoria
Peter MacCallum
Melbourne, Victoria, Australia, 8006
Austria
PET-CT Linz - St. Vicent's Hospital
Linz, Austria
Portugal
Hospitais da Universidade de Coimbra
Coimbra, Portugal
Switzerland
University Hospital Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
American College of Radiology - Image Metrix
World Molecular Imaging Society
Investigators
Principal Investigator: Johannes Czernin, MD World Molecular Imaging Society
  More Information

Responsible Party: American College of Radiology - Image Metrix
ClinicalTrials.gov Identifier: NCT00882609     History of Changes
Other Study ID Numbers: AMI-2008-01 
Study First Received: April 15, 2009
Last Updated: November 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by American College of Radiology - Image Metrix:
bone metastasis
bone metastases
Sodium Fluoride
F18 Fluoride
bone scan

Additional relevant MeSH terms:
Neoplasm Metastasis
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Fluorides
Sodium Fluoride
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents

ClinicalTrials.gov processed this record on December 02, 2016