F18PET/CT Versus TC-MDP Scanning to Detect Bone Mets
This study is currently recruiting participants.
Verified November 2012 by American College of Radiology - Image Metrix
Sponsor:
American College of Radiology - Image Metrix
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
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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
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 | |
| 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 | |
| Cedar-Sinai Medical Center | Terminated |
| Los Angeles, California, United States, 90048 | |
| 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 | |
| Saint Louis University | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| Contact: Martha Edwards 314-577-8048 edwardsm@slu.edu | |
| Principal Investigator: Medhat Osman, 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 | |
| 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:
|
Fluorides Sodium Fluoride Neoplasm Metastasis Bone Neoplasms Bone Marrow Diseases Neoplastic Processes Neoplasms Pathologic Processes |
Neoplasms by Site Bone Diseases Musculoskeletal Diseases Hematologic Diseases Cariostatic Agents Protective Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013