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

The recruitment status of this study is unknown because the information has not been verified recently.
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
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

Contacts
Contact: Johannes Czernin, MD (310) 983-1443 JCzernin@mednet.ucla.edu

Locations
United States, Arizona
Scottsdale Medical Imaging Recruiting
Scottsdale, Arizona, United States, 85252
Contact: Jocelyn Harmon    480-425-4181    jharmon@esmil.com   
Principal Investigator: Ronald Korn, MD         
United States, California
Silicon Valley Imaging Completed
Freemont, California, United States, 94538
Cedar-Sinai Medical Center Terminated
Los Angeles, California, United States, 90048
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         
VA West Los Angles Medical Center Recruiting
Los Angeles, California, United States, 90073
Contact: Gholam Berenji, MD    310-478-3711      
Principal Investigator: Gholam Berenji, MD         
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Lindee Burton    650-725-4712    lburton@stanford.edu   
Principal Investigator: Samjiv Gambhir, MD         
United States, Georgia
SouthCoast Imaging Center Recruiting
Savannah, Georgia, United States, 31406
Contact: Nicole Couturier    912-691-4200    ncouturier@southcoastmedical.com   
Principal Investigator: Patricia Shapiro, MD         
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Kristine Wernette    734-936-5894    krisw@med.umich.edu   
Principal Investigator: Morand Piert, MD         
United States, Missouri
Saint Luke's Hospital Recruiting
Kansas City, Missouri, United States, 64111
Contact: Trent West    816-932-3502      
Principal Investigator: Pablo Delgado, MD         
John Cochran Veterans Administration Recruiting
Saint Louis, Missouri, United States, 63106
Contact: Ryan Warhoover    314-289-7925    ryan.warhoover@va.gov   
Principal Investigator: Medhat Osman, MD         
Saint Louis University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Martha Edwards    314-577-8048    edwardsm@slu.edu   
Principal Investigator: Medhat Osman, MD         
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Suzanne Lenz    603-653-3520    suzanne.b.lenz@hitchcock.org   
Principal Investigator: Seltzer Marc, MD         
United States, New York
New York Presbyterian Weill Cornell Recruiting
New York, New York, United States, 10065
Contact: Ame Ng    212-746-2194    ameng@med.cornell.edu   
Principal Investigator: Pablo Delgado, MD         
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Louis Kidd    713-563-0633      
Principal Investigator: Homer Macapinlac, MD         
United States, Utah
University of Utah School of Medicine Recruiting
Salt Lake, Utah, United States, 84112
Contact: Britney Beardmore    801-585-0176    britney.beardmore@hcu-utah.edu   
Contact: Regan Butterfield       regan.butterfield@hcu-utah.edu   
Principal Investigator: John Hoffman         
Australia, Victoria
Peter MacCallum Recruiting
Melbourne, Victoria, Australia, 8006
Contact: Elizabeth Drummond    61 3 9656 1856    elizabeth.drummond@petermac.org   
Principal Investigator: Michael Hofman, MD         
Austria
PET-CT Linz - St. Vicent's Hospital Recruiting
Linz, Austria
Contact: Mohsen Beheshti, MD    43 732 7677 7077      
Principal Investigator: Werner Langsteger, MD         
Portugal
Hospitais da Universidade de Coimbra Recruiting
Coimbra, Portugal
Contact: Paula Lapa, MD    351 239 400615    paulalapa@huc.min-saude.pt   
Principal Investigator: Joao de Lima, MD         
Switzerland
University Hospital Zurich Completed
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

No publications provided

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:
Bone Marrow Diseases
Bone Neoplasms
Neoplasm Metastasis
Bone Diseases
Hematologic Diseases
Musculoskeletal Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Fluorides
Sodium Fluoride
Cariostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on November 24, 2014