Full Text View
Tabular View
No Study Results Posted
Related Studies
F18PET/CT Versus TC-MDP Scanning to Detect Bone Mets
This study is currently recruiting participants.
Verified by American College of Radiology - Image Metrix, April 2009
First Received: April 15, 2009   No Changes Posted
Sponsors and Collaborators: American College of Radiology - Image Metrix
Academy of Molecular Imaging
Information provided by: American College of Radiology - Image Metrix
ClinicalTrials.gov Identifier: NCT00882609
  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
Bone Metastases

MedlinePlus related topics: Cancer Nuclear Scans
Drug Information available for: Fluoride Sodium fluoride
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
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

Further study details as provided by American College of Radiology - Image Metrix:

Estimated Enrollment: 550
Study Start Date: January 2009
Groups/Cohorts
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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) 206-3226 JCzernin@mednet.ucla.edu

Locations
United States, Arizona
Scottsdale Medical Imaging Recruiting
Scottsdale, Arizona, United States, 85252
Contact: Maya Hernandez     480-425-4191     mhern@esmil.com    
Principal Investigator: Ronald Korn, MD            
United States, California
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            
Sponsors and Collaborators
American College of Radiology - Image Metrix
Academy of Molecular Imaging
  More Information

No publications provided

Responsible Party: Academy of Molecular Imaging ( Johannes Czernin, MD )
Study ID Numbers: AMI-2008-01
Study First Received: April 15, 2009
Last Updated: April 15, 2009
ClinicalTrials.gov Identifier: NCT00882609     History of Changes
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

Study placed in the following topic categories:
Musculoskeletal Diseases
Bone Neoplasms
Hematologic Diseases
Neoplasm Metastasis
Fluorides
Bone Marrow Diseases
Bone Diseases

Additional relevant MeSH terms:
Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Musculoskeletal Diseases
Bone Neoplasms
Hematologic Diseases
Neoplasm Metastasis
Bone Marrow Diseases
Bone Diseases

ClinicalTrials.gov processed this record on May 06, 2009