Breast Cancer Clinical Trial

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

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.

View Full Description

Full 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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

550

Study ID:

NCT00882609

Recruitment Status:

Unknown status

Sponsor:

American College of Radiology - Image Metrix

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There are 17 Locations for this study

See Locations Near You

Scottsdale Medical Imaging
Scottsdale Arizona, 85252, United States More Info
Jocelyn Harmon
Contact
480-425-4181
[email protected]
Ronald Korn, MD
Principal Investigator
Silicon Valley Imaging
Freemont California, 94538, United States
Cedar-Sinai Medical Center
Los Angeles California, 90048, United States
VA West Los Angles Medical Center
Los Angeles California, 90073, United States More Info
Gholam Berenji, MD
Contact
310-478-3711
Gholam Berenji, MD
Principal Investigator
UCLA
Los Angeles California, 90095, United States More Info
Martin A Auerbach, MD
Contact
310-983-1444
[email protected]
Martin Auerbach, MD
Principal Investigator
Stanford University Medical Center
Stanford California, 94305, United States More Info
Lindee Burton
Contact
650-725-4712
[email protected]
Samjiv Gambhir, MD
Principal Investigator
SouthCoast Imaging Center
Savannah Georgia, 31406, United States More Info
Nicole Couturier
Contact
912-691-4200
[email protected]
Patricia Shapiro, MD
Principal Investigator
University of Michigan Health System
Ann Arbor Michigan, 48109, United States More Info
Kristine Wernette
Contact
734-936-5894
[email protected]
Morand Piert, MD
Principal Investigator
Saint Luke's Hospital
Kansas City Missouri, 64111, United States More Info
Trent West
Contact
816-932-3502
Pablo Delgado, MD
Principal Investigator
John Cochran Veterans Administration
Saint Louis Missouri, 63106, United States More Info
Ryan Warhoover
Contact
314-289-7925
[email protected]
Medhat Osman, MD
Principal Investigator
Saint Louis University
Saint Louis Missouri, 63110, United States More Info
Martha Edwards
Contact
314-577-8048
[email protected]
Medhat Osman, MD
Principal Investigator
Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States More Info
Suzanne Lenz
Contact
603-653-3520
[email protected]
Seltzer Marc, MD
Principal Investigator
New York Presbyterian Weill Cornell
New York New York, 10065, United States More Info
Pablo Delgado, MD
Principal Investigator
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Louis Kidd
Contact
713-563-0633
Homer Macapinlac, MD
Principal Investigator
University of Utah School of Medicine
Salt Lake Utah, 84112, United States More Info
Britney Beardmore
Contact
801-585-0176
[email protected]
Regan Butterfield
Contact
[email protected]
John Hoffman
Principal Investigator
Peter MacCallum
Melbourne Victoria, 8006, Australia More Info
Elizabeth Drummond
Contact
61 3 9656 1856
[email protected]
Michael Hofman, MD
Principal Investigator
PET-CT Linz - St. Vicent's Hospital
Linz , , Austria More Info
Mohsen Beheshti, MD
Contact
43 732 7677 7077
Werner Langsteger, MD
Principal Investigator
Hospitais da Universidade de Coimbra
Coimbra , , Portugal More Info
Paula Lapa, MD
Contact
351 239 400615
[email protected]
Joao de Lima, MD
Principal Investigator
University Hospital Zurich
Zurich , 8091, Switzerland

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

550

Study ID:

NCT00882609

Recruitment Status:

Unknown status

Sponsor:


American College of Radiology - Image Metrix

How clear is this clinincal trial information?

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