Clinical trial NCT00882609: F18PET/CT Versus TC-MDP Scanning to Detect Bone Mets
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Bone Metastases
Keywords: bone metastasis
bone metastases
Sodium Fluoride
F18 Fluoride
bone scan
Lead sponsor: American College of Radiology - Image Metrix
Sponsor class: INDUSTRY
Collaborators: name: World Molecular Imaging Society
First posted: 2009-04-16
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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). 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.

Eligibility 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

Primary outcomes:
measure: Analysis of the diagnostic performance of [18F]NaF fluoride PET/CT scanning
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Medical Imaging
state: Arizona
city: Freemont
country: United States
facility: Silicon Valley Imaging
state: California
city: Los Angeles
country: United States
facility: Cedar-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: VA West Los Angles Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Savannah
country: United States
facility: SouthCoast Imaging Center
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Kansas City
country: United States
facility: Saint Luke's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: John Cochran Veterans Administration
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: New York Presbyterian Weill Cornell
state: New York
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Salt Lake
country: United States
facility: University of Utah School of Medicine
state: Utah
city: Melbourne
country: Australia
facility: Peter MacCallum
state: Victoria
city: Linz
country: Austria
facility: PET-CT Linz - St. Vicent's Hospital
city: Coimbra
country: Portugal
facility: Hospitais da Universidade de Coimbra
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: World Molecular Imaging Society
name: Johannes Czernin, MD
role: PRINCIPAL_INVESTIGATOR
References: