Recruiting

Phase 3

18F-Fluoride PET/CT vs. Conventional Bone ScanningF18PET/CT Versus TC-MDP Scanning to Detect Bone Mets

Sponsor:

American College of Radiology - Image Metrix

Code:

NCT00882609

Conditions

Bone Metastases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bone Scan: F18-Fluoride PET/CT or TC-MDP

Study Details

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.

Conditions

Bone Metastases

Study ID

NCT00882609

Start date

Jan, 2009

Status verified date

Nov, 2012

Completion date

Jun, 2013

Anticipated

Primary completion date

Dec, 2012

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

550 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

experimental: F18-Fluoride PET/CT

Interventions

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.

Primary outcome measure

Analysis of the diagnostic performance of [18F]NaF fluoride PET/CT scanning [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Johannes Czernin, MD

(310) 983-1443 JCzernin@mednet.ucla.edu

Locations

Scottsdale Medical Imaging

Recruiting

Scottsdale, Arizona, United States, 85252

Contacts

Jocelyn Harmon

480-425-4181 jharmon@esmil.com

Principal Investigator:

Ronald Korn, MD

VA West Los Angles Medical Center

Recruiting

Los Angeles, California, United States, 90073

Contacts

Gholam Berenji, MD

310-478-3711

Principal Investigator:

Gholam Berenji, MD

UCLA

Recruiting

Los Angeles, California, United States, 90095

Contacts

Martin A Auerbach, MD

310-983-1444 mauerbach@mednet.ucla.net

Principal Investigator:

Martin Auerbach, MD

Stanford University Medical Center

Recruiting

Stanford, California, United States, 94305

Contacts

Lindee Burton

650-725-4712 lburton@stanford.edu

Principal Investigator:

Samjiv Gambhir, MD

SouthCoast Imaging Center

Recruiting

Savannah, Georgia, United States, 31406

Contacts

Nicole Couturier

912-691-4200 ncouturier@southcoastmedical.com

Principal Investigator:

Patricia Shapiro, MD

University of Michigan Health System

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Kristine Wernette

734-936-5894 krisw@med.umich.edu

Principal Investigator:

Morand Piert, MD

Saint Luke's Hospital

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Trent West

816-932-3502

Principal Investigator:

Pablo Delgado, MD

John Cochran Veterans Administration

Recruiting

Saint Louis, Missouri, United States, 63106

Contacts

Ryan Warhoover

314-289-7925 ryan.warhoover@va.gov

Principal Investigator:

Medhat Osman, MD

Saint Louis University

Recruiting

Saint Louis, Missouri, United States, 63110

Contacts

Martha Edwards

314-577-8048 edwardsm@slu.edu

Principal Investigator:

Medhat Osman, MD

Dartmouth-Hitchcock Medical Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Suzanne Lenz

603-653-3520 suzanne.b.lenz@hitchcock.org

Principal Investigator:

Seltzer Marc, MD

New York Presbyterian Weill Cornell

Recruiting

New York, New York, United States, 10065

Contacts

Ame Ng

212-746-2194 ameng@med.cornell.edu

Principal Investigator:

Pablo Delgado, MD

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Louis Kidd

713-563-0633

Principal Investigator:

Homer Macapinlac, MD

University of Utah School of Medicine

Recruiting

Salt Lake, Utah, United States, 84112

Contacts

Britney Beardmore

801-585-0176 britney.beardmore@hcu-utah.edu

Regan Butterfield

regan.butterfield@hcu-utah.edu

Principal Investigator:

John Hoffman

More Information

Sponsor

American College of Radiology - Image Metrix

Last update posted

Nov 29, 2012

Last verified

Nov, 2012

Keywords

bone metastasis
bone metastases
Sodium Fluoride
F18 Fluoride
bone scan

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by American College of Radiology - Image Metrix on 2012-11-29.