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18F-Fluoride PET/CT Versus 99mTc-MDP Scanning for Detecting Bone Metastases: A Randomized, Multi-Center Trial to Compare Two Bone Imaging Techniques

Phase 3
18 Years
Open (Enrolling)
Bone Metastases

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Trial Information

18F-Fluoride PET/CT Versus 99mTc-MDP Scanning for Detecting Bone Metastases: A Randomized, Multi-Center Trial to Compare Two Bone Imaging Techniques

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.

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

Type of Study:


Study Design:

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

Outcome Measure:

Analysis of the diagnostic performance of [18F]NaF fluoride PET/CT scanning

Outcome Description:

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.

Outcome Time Frame:

6 Months

Safety Issue:


Principal Investigator

Johannes Czernin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

World Molecular Imaging Society


United States: Food and Drug Administration

Study ID:




Start Date:

January 2009

Completion Date:

June 2013

Related Keywords:

  • Bone Metastases
  • bone metastasis
  • bone metastases
  • Sodium Fluoride
  • F18 Fluoride
  • bone scan
  • Neoplasm Metastasis
  • Bone Neoplasms
  • Bone Marrow Diseases



Stanford University Medical Center Stanford, California  94305-5408
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756
Saint Luke's Hospital Chesterfield, Missouri  63017
Saint Louis University St. Louis, Missouri  63104
University of Texas MD Anderson Cancer Center Houston, Texas  77030
UCLA Los Angeles, California  90095
University of Utah School of Medicine Salt Lake City, Utah  84132
University of Michigan Health System Ann Arbor, Michigan  
Scottsdale Medical Imaging Scottsdale, Arizona  85258
Silicon Valley Imaging Freemont, California  94538
VA West Los Angles Medical Center Los Angeles, California  90073
Cedar-Sinai Medical Center Los Angeles, California  90048
SouthCoast Imaging Center Savannah, Georgia  31406
John Cochran Veterans Administration Saint Louis, Missouri  63106
New York Presbyterian Weill Cornell New York, New York  10065