F18PET/CT Versus TC-MDP Scanning to Detect Bone Mets

NCT00882609 | Unknown Phase 3

• 1 other identifier: AMI-2008-01
• Study Type: interventional
• Target: 550
• Locations: 4 countries
• Sites: 18

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

Keywords

bone metastasis; bone metastases; Sodium Fluoride; F18 Fluoride; bone scan

Outcome Measures

Primary Outcomes (1)

• 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.

  6 Months

Study Arms (2)

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

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

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

Interventions

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

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.

F18-Fluoride PET/CT; TC-MDP Bone Scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• American College of Radiology - Image Metrix: lead
• World Molecular Imaging Society: collaborator

Study Sites (19)

Scottsdale Medical Imaging

Scottsdale, Arizona, 85252, United States

RECRUITING

Silicon Valley Imaging

Freemont, California, 94538, United States

COMPLETED

Cedar-Sinai Medical Center

Los Angeles, California, 90048, United States

TERMINATED

VA West Los Angles Medical Center

Los Angeles, California, 90073, United States

RECRUITING

UCLA

Los Angeles, California, 90095, United States

RECRUITING

Stanford University Medical Center

Stanford, California, 94305, United States

RECRUITING

SouthCoast Imaging Center

Savannah, Georgia, 31406, United States

RECRUITING

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

RECRUITING

Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

RECRUITING

John Cochran Veterans Administration

St Louis, Missouri, 63106, United States

RECRUITING

Saint Louis University

St Louis, Missouri, 63110, United States

RECRUITING

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

New York Presbyterian Weill Cornell

New York, New York, 10065, United States

RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

University of Utah School of Medicine

Salt Lake City, Utah, 84112, United States

RECRUITING

Peter MacCallum

Melbourne, Victoria, 8006, Australia

RECRUITING

PET-CT Linz - St. Vicent's Hospital

Linz, Linz, Austria

RECRUITING

Hospitais da Universidade de Coimbra

Coimbra, Portugal, Portugal

RECRUITING

University Hospital Zurich

Zurich, Switzerland, 8091, Switzerland

COMPLETED

Study Officials

• Johannes Czernin, MD

  World Molecular Imaging Society

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johannes Czernin, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2009
• First Posted: April 16, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: November 29, 2012

Record last verified: 2012-11

Locations

CH (1); AU (1); US (15); PT (1)