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

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:

MedlinePlus related topics: Diagnostic Imaging Nuclear Scans

Drug Information available for: Sodium fluoride Fluorine Fluoride Listerine

Genetic and Rare Diseases Information Center resources: Bone Cancer

U.S. FDA Resources

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.

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

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
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
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
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


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 September 29, 2016