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

Primary Purpose

Bone Metastases

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bone Scan: F18-Fluoride PET/CT or TC-MDP
Sponsored by
American College of Radiology - Image Metrix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bone Metastases focused on measuring bone metastasis, bone metastases, Sodium Fluoride, F18 Fluoride, bone scan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Scottsdale Medical ImagingRecruiting
  • Silicon Valley Imaging
  • Cedar-Sinai Medical Center
  • VA West Los Angles Medical CenterRecruiting
  • UCLARecruiting
  • Stanford University Medical CenterRecruiting
  • SouthCoast Imaging CenterRecruiting
  • University of Michigan Health SystemRecruiting
  • Saint Luke's HospitalRecruiting
  • John Cochran Veterans AdministrationRecruiting
  • Saint Louis UniversityRecruiting
  • Dartmouth-Hitchcock Medical CenterRecruiting
  • New York Presbyterian Weill CornellRecruiting
  • University of Texas MD Anderson Cancer CenterRecruiting
  • University of Utah School of MedicineRecruiting
  • Peter MacCallumRecruiting
  • PET-CT Linz - St. Vicent's HospitalRecruiting
  • Hospitais da Universidade de CoimbraRecruiting
  • University Hospital Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

TC-MDP Bone Scan

F18-Fluoride PET/CT

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 15, 2009
Last Updated
November 28, 2012
Sponsor
American College of Radiology - Image Metrix
Collaborators
World Molecular Imaging Society
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1. Study Identification

Unique Protocol Identification Number
NCT00882609
Brief Title
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

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American College of Radiology - Image Metrix
Collaborators
World Molecular Imaging Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Metastases
Keywords
bone metastasis, bone metastases, Sodium Fluoride, F18 Fluoride, bone scan

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TC-MDP Bone Scan
Arm Type
Active Comparator
Arm Description
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
Arm Title
F18-Fluoride PET/CT
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Bone Scan: F18-Fluoride PET/CT or TC-MDP
Intervention Description
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 Information:
Title
Analysis of the diagnostic performance of [18F]NaF fluoride PET/CT scanning
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.
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Johannes Czernin, MD
Phone
(310) 983-1443
Email
JCzernin@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johannes Czernin, MD
Organizational Affiliation
World Molecular Imaging Society
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scottsdale Medical Imaging
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85252
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jocelyn Harmon
Phone
480-425-4181
Email
jharmon@esmil.com
First Name & Middle Initial & Last Name & Degree
Ronald Korn, MD
Facility Name
Silicon Valley Imaging
City
Freemont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Individual Site Status
Completed
Facility Name
Cedar-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Terminated
Facility Name
VA West Los Angles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gholam Berenji, MD
Phone
310-478-3711
First Name & Middle Initial & Last Name & Degree
Gholam Berenji, MD
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin A Auerbach, MD
Phone
310-983-1444
Email
mauerbach@mednet.ucla.net
First Name & Middle Initial & Last Name & Degree
Martin Auerbach, MD
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindee Burton
Phone
650-725-4712
Email
lburton@stanford.edu
First Name & Middle Initial & Last Name & Degree
Samjiv Gambhir, MD
Facility Name
SouthCoast Imaging Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Couturier
Phone
912-691-4200
Email
ncouturier@southcoastmedical.com
First Name & Middle Initial & Last Name & Degree
Patricia Shapiro, MD
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristine Wernette
Phone
734-936-5894
Email
krisw@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Morand Piert, MD
Facility Name
Saint Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trent West
Phone
816-932-3502
First Name & Middle Initial & Last Name & Degree
Pablo Delgado, MD
Facility Name
John Cochran Veterans Administration
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Warhoover
Phone
314-289-7925
Email
ryan.warhoover@va.gov
First Name & Middle Initial & Last Name & Degree
Medhat Osman, MD
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martha Edwards
Phone
314-577-8048
Email
edwardsm@slu.edu
First Name & Middle Initial & Last Name & Degree
Medhat Osman, MD
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanne Lenz
Phone
603-653-3520
Email
suzanne.b.lenz@hitchcock.org
First Name & Middle Initial & Last Name & Degree
Seltzer Marc, MD
Facility Name
New York Presbyterian Weill Cornell
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ame Ng
Phone
212-746-2194
Email
ameng@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Pablo Delgado, MD
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis Kidd
Phone
713-563-0633
First Name & Middle Initial & Last Name & Degree
Homer Macapinlac, MD
Facility Name
University of Utah School of Medicine
City
Salt Lake
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Britney Beardmore
Phone
801-585-0176
Email
britney.beardmore@hcu-utah.edu
First Name & Middle Initial & Last Name & Degree
Regan Butterfield
Email
regan.butterfield@hcu-utah.edu
First Name & Middle Initial & Last Name & Degree
John Hoffman
Facility Name
Peter MacCallum
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
8006
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Drummond
Phone
61 3 9656 1856
Email
elizabeth.drummond@petermac.org
First Name & Middle Initial & Last Name & Degree
Michael Hofman, MD
Facility Name
PET-CT Linz - St. Vicent's Hospital
City
Linz
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohsen Beheshti, MD
Phone
43 732 7677 7077
First Name & Middle Initial & Last Name & Degree
Werner Langsteger, MD
Facility Name
Hospitais da Universidade de Coimbra
City
Coimbra
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula Lapa, MD
Phone
351 239 400615
Email
paulalapa@huc.min-saude.pt
First Name & Middle Initial & Last Name & Degree
Joao de Lima, MD
Facility Name
University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Completed

12. IPD Sharing Statement

Learn more about this trial

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

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