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Sponsors and Collaborators: |
Naviscan PET Systems Certus International, Contract Research Organization NIH/NCI Grant 5 R44 CA103102 - 05 |
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Information provided by: | Naviscan PET Systems |
ClinicalTrials.gov Identifier: | NCT00484614 |
Women with newly diagnosed breast cancer anticipating breast-conserving surgery are enrolled into the study and will undergo both high-resolution positron emission mammographic (PEM) imaging and contrast-enhanced magnetic resonance imaging (MRI) of the breast(s). The purpose of this study is to determine changes in surgical management resulting from PEM or MRI imaging as compared to conventional imaging and to determine if the changes were appropriate with histopathology as gold standard.
Condition | Intervention | Phase |
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Breast Cancer |
Procedure: Positron Emission Mammography Procedure: Magnetic Resonance Imaging |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Single Blind (Investigator), Uncontrolled, Crossover Assignment, Efficacy Study |
Official Title: | Prospective Multicenter Study of the Role of Positron Emission Mammography (PEM) in Pre-Surgical Planning for Breast Cancer |
Enrollment: | 472 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | March 2009 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1 PEM: Active Comparator |
Procedure: Positron Emission Mammography
Molecular Imaging Device
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2 MRI: Active Comparator |
Procedure: Magnetic Resonance Imaging
Imaging Device
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Breast compression and/or immobilization during positron emission tomographic (PET) imaging has been called positron emission mammography, or "PEM," and the device used to perform the scan has been called a PEM Scanner. This protocol is designed as a prospective multi-center clinical trial to evaluate the role of high resolution PEM, used in combination with the radiotracer 2-[F-18]- fluorodeoxyglucose (FDG), in pre-surgical planning in women with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e. lumpectomy) after full workup with mammography, clinical breast exam, and additional US as would normally be performed. Participants will undergo both contrast enhanced MRI and PEM imaging. In order to control for potential bias in interpretation of the second examination (i.e. PEM or MRI), the order of interpretation of these examinations will be randomly assigned at study entry.The primary objective of the study is to determine changes in surgical management resulting from PEM or MRI or both, separately and in conjunction with conventional imaging and to determine whether these changes were appropriate (i.e. to excise malignancy) or inappropriate (e.g. wider excision or mastectomy for what proved to be benign disease).
Ages Eligible for Study: | 25 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
No contraindications to breast MRI:
Exclusion Criteria:
United States, California | |
Scripps Cancer Center | |
San Diego, California, United States, 92121 | |
University of Southern California | |
Los Angeles, California, United States, 90033 | |
United States, Florida | |
Boca Raton Community Hospital | |
Boca Raton, Florida, United States, 33486 | |
United States, Maryland | |
Anne Arundel Medical Center | |
Annapolis, Maryland, United States, 21401 | |
American Radiology Services, Inc., Johns Hopkins Green Spring | |
Lutherville, Maryland, United States, 21093 | |
United States, North Carolina | |
University of North Carolina School of Medicine | |
Chapel Hill, North Carolina, United States, 27599 |
Study Director: | Wendie A Berg, MD, Ph.D | American Radiology Services, Johns Hopkins Greenspring, Lutherville, MD |
Principal Investigator: | Etta Pisano, MD, FACR | University of North Carolina School of Medicine, Chapel Hill, NC |
Principal Investigator: | Kathy Schilling, MD | Boca Raton Community Hospital, Boca Raton, FL |
Principal Investigator: | Marie Tartar, MD | Scripps Cancer Center, San Diego, CA |
Principal Investigator: | Linda Hovanessian Larsen, MD | USC Norris Cancer Center |
Principal Investigator: | Lorraine Tafra, MD | Anne Arundel Medical Center, MD |
Responsible Party: | Naviscan PET Systems, Inc ( Judith E Kalinyak, Medical Director ) |
Study ID Numbers: | PEM-06-01, NIH Grant: 5 R44 CA103102-05 |
Study First Received: | June 8, 2007 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00484614 History of Changes |
Health Authority: | United States: Institutional Review Board |
Breast Cancer, breast conserving surgery |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |