Bone MetastasesPhase 3NCT00882609
F18PET/CT Versus TC-MDP Scanning to Detect Bone Mets
A Phase 3 study testing Bone Scan: F18-Fluoride PET/CT or TC-MDP in people with Bone Metastases, run by American College of Radiology - Image Metrix at 19 sites in 5 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases
- What is being tested?
- Bone Scan: F18-Fluoride PET/CT or TC-MDP
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 19 sitesin 5 countries
- Study dates
- Jan 2009to Jun 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
19 sites in 5 countries.
19 sites in 5 countries
United States15 sites, 13 recruiting
- Recruiting
University of Michigan Health System
Ann Arbor, Michigan, 48109
Kristine Wernette, 734-936-5894, krisw@med.umich.edu
Morand Piert, MD
- Completed
Silicon Valley Imaging
Freemont, California, 94538
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Louis Kidd, 713-563-0633
Homer Macapinlac, MD
- Recruiting
Saint Luke's Hospital
Kansas City, Missouri, 64111
Trent West, 816-932-3502
Pablo Delgado, MD
- Recruiting
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Suzanne Lenz, 603-653-3520, suzanne.b.lenz@hitchcock.org
Seltzer Marc, MD
- Terminated
Cedar-Sinai Medical Center
Los Angeles, California, 90048
- Recruiting
VA West Los Angles Medical Center
Los Angeles, California, 90073
Gholam Berenji, MD, 310-478-3711
Gholam Berenji, MD
- Recruiting
UCLA
Los Angeles, California, 90095
Martin A Auerbach, MD, 310-983-1444, mauerbach@mednet.ucla.net
Martin Auerbach, MD
- Recruiting
New York Presbyterian Weill Cornell
New York, New York, 10065
Ame Ng, 212-746-2194, ameng@med.cornell.edu
Pablo Delgado, MD
- Recruiting
University of Utah School of Medicine
Salt Lake City, Utah, 84112
Britney Beardmore, 801-585-0176, britney.beardmore@hcu-utah.edu
Regan Butterfield, regan.butterfield@hcu-utah.edu
- Recruiting
SouthCoast Imaging Center
Savannah, Georgia, 31406
Nicole Couturier, 912-691-4200, ncouturier@southcoastmedical.com
Patricia Shapiro, MD
- Recruiting
Scottsdale Medical Imaging
Scottsdale, Arizona, 85252
Jocelyn Harmon, 480-425-4181, jharmon@esmil.com
Ronald Korn, MD
- Recruiting
John Cochran Veterans Administration
St Louis, Missouri, 63106
Ryan Warhoover, 314-289-7925, ryan.warhoover@va.gov
Medhat Osman, MD
- Recruiting
Saint Louis University
St Louis, Missouri, 63110
Martha Edwards, 314-577-8048, edwardsm@slu.edu
Medhat Osman, MD
- Recruiting
Stanford University Medical Center
Stanford, California, 94305
Lindee Burton, 650-725-4712, lburton@stanford.edu
Samjiv Gambhir, MD
Australia1 site, 1 recruiting
- Recruiting
Peter MacCallum
Melbourne, Victoria, 8006
Elizabeth Drummond, 61 3 9656 1856, elizabeth.drummond@petermac.org
Michael Hofman, MD
Austria1 site, 1 recruiting
- Recruiting
PET-CT Linz - St. Vicent's Hospital
Linz, Linz
Mohsen Beheshti, MD, 43 732 7677 7077
Werner Langsteger, MD
Portugal1 site, 1 recruiting
- Recruiting
Hospitais da Universidade de Coimbra
Coimbra, Portugal
Paula Lapa, MD, 351 239 400615, paulalapa@huc.min-saude.pt
Joao de Lima, MD
Switzerland1 site
- Completed
University Hospital Zurich
Zurich, Switzerland, 8091
About this study
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
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.
Read the 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.
- Conditions
- Bone Metastases
- Being tested
- Bone Scan: F18-Fluoride PET/CT or TC-MDP
- Keywords
- bone metastasis, bone metastases, Sodium Fluoride, F18 Fluoride, bone scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Scan: F18-Fluoride PET/CT or TC-MDPDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TC-MDP Bone Scan | Active comparator | 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 Receives: Device: Bone Scan: F18-Fluoride PET/CT or TC-MDP |
| F18-Fluoride PET/CT | Experimental | 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 Receives: Device: Bone Scan: F18-Fluoride PET/CT or TC-MDP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of the diagnostic performance of [18F]NaF fluoride PET/CT scanning
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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American College of Radiology - Image Metrix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- World Molecular Imaging Society
- Responsible party
- Sponsor
- Investigators
- Johannes Czernin, MD, Principal investigator, World Molecular Imaging Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00882609
- Sponsor's protocol ID
- AMI-2008-01
- Status last verified
- Nov 2012
- First submitted
- 15 Apr 2009
- Last updated
- 29 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00882609
- Acronym / sponsor ID
- AMI-2008-01
- Conditions
- Bone Metastases
- Keywords
- bone metastasis, bone metastases, Sodium Fluoride, F18 Fluoride, bone scan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- American College of Radiology - Image MetrixIndustry (pharma, biotech, devices)
- Collaborators
- World Molecular Imaging Society
- Study start
- Jan 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 16 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TC-MDP Bone Scan | Active comparator | Device: Bone Scan: F18-Fluoride PET/CT or TC-MDPPatients 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 |
| F18-Fluoride PET/CT | Experimental | Device: Bone Scan: F18-Fluoride PET/CT or TC-MDPPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- Patient is < 18 years old at the time of the drug administration
- Patient is pregnant or nursing;
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Scan: F18-Fluoride PET/CT or TC-MDPEach 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. | Device | F18-Fluoride PET/CT, TC-MDP Bone Scan |
Primary outcome
Analysis of the diagnostic performance of [18F]NaF fluoride PET/CT scanning
Time frame: 6 Months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes Czernin, MD principal investigator
World Molecular Imaging Society
19 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bone Scan: F18-Fluoride PET/CT or TC-MDP in people with Bone Metastases, run by American College of Radiology - Image Metrix at 19 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Australia, Austria, Portugal, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johannes Czernin, MD ((310) 983-1443, JCzernin@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the diagnostic performance of [18F]NaF fluoride PET/CT scanning (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2012.