Study the Role of Positron Emission Mammography in Pre-surgical Planning for Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00484614
Recruitment Status : Unknown
Verified December 2008 by Naviscan PET Systems.
Recruitment status was:  Active, not recruiting
First Posted : June 11, 2007
Last Update Posted : September 3, 2009
Certus International, Inc.
Information provided by:
Naviscan PET Systems

June 8, 2007
June 11, 2007
September 3, 2009
September 2006
November 2008   (Final data collection date for primary outcome measure)
The primary outcome for this study will be measured by evidence of malignancy on PEM and/or MRI, confirmed by core biopsy or surgery. [ Time Frame: Within 30 days (plus or minus a week) after core biopsy/surgery ]
Same as current
Complete list of historical versions of study NCT00484614 on Archive Site
Risk of false positive examinations with either PEM or MRI imaging with surgery as gold standard [ Time Frame: Within the first 30 days (plus or minus 7 days) after surgery ]
Same as current
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Not Provided
Study the Role of Positron Emission Mammography in Pre-surgical Planning for Breast Cancer
Prospective Multicenter Study of the Role of Positron Emission Mammography (PEM) in Pre-Surgical Planning for Breast Cancer
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.
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).
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Breast Cancer
  • Procedure: Positron Emission Mammography
    Molecular Imaging Device
    Other Name: Naviscan PET Systems, PEM Flex Solo
  • Procedure: Magnetic Resonance Imaging
    Imaging Device
  • Active Comparator: 1 PEM
    Intervention: Procedure: Positron Emission Mammography
  • Active Comparator: 2 MRI
    Intervention: Procedure: Magnetic Resonance Imaging

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
March 2009
November 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Women who are 25 years of age or older
  2. Newly diagnosed core-biopsy proven breast cancer
  3. Has current mammography of all study breasts (within prior 3 months), including magnification views of suspicious calcifications (if any)
  4. Recent clinical breast examination (within prior 3 months)
  5. Has had full diagnostic workup with breast ultrasound (within prior 3 months) as indicated by mammographic and/or clinical findings
  6. Has had percutaneous biopsy of all relevant suspicious findings on mammography, clinical examination, and ultrasound
  7. After full diagnostic workup, participant is likely to be a candidate for breast conserving surgery.
  8. No contraindications to breast MRI:

    • No pacemaker, aneurysm clip, or other implanted magnetic or ferromagnetic device;
    • No claustrophobia that cannot be controlled by medication with valium, ativan, or other sedative under her physician's orders;
    • Has intravenous access;
    • Weight < 300 lbs;
    • Physically able to tolerate positioning in the MRI scanner.
  9. Agrees to undergo follow-up MRI or PEM at 6 months and/or MRI-guided vacuum-assisted biopsy, US-guided core biopsy, or PEM-guided biopsy if needed based on results of the MRI or PEM examination
  10. Has signed study-specific consent form
  11. Subject agrees to undergo a contrast-enhanced MRI and PEM scan within five business days of each other, prior to surgery.

Exclusion Criteria:

  1. Male
  2. Pregnancy
  3. Active lactation or discontinued breastfeeding < 2 months prior
  4. Age less than 25 years
  5. Inability to provide informed consent
  6. Prior radiation treatment to the affected breast(s)
  7. Participant is scheduled for sentinel node procedure using radioactive Tc-99m within 24 hours after the scheduled PEM Flex study
  8. Women planning prophylactic mastectomy without histologic confirmation
  9. Individuals who are electing to undergo neoadjuvant chemotherapy prior to surgery (Note: Patients with prior contralateral breast cancer receiving chemoprevention with Tamoxifen, Arimidex, or other aromatase inhibitor are eligible)
  10. Individuals who have had surgery on the study breast(s) within the past 12 months
  11. Breast implant(s) in any study breast(s)
  12. Women who have had distant metastatic disease either currently or in the past
  13. Individuals with Type I or poorly controlled Type II diabetes mellitus
  14. Individuals with a blood glucose level that is above 140 mg/dl at the time of PEM imaging
  15. Has not had contrast-enhanced breast MRI or PEM within the past 12 months prior to study enrollment
  16. Subject is currently enrolled in another breast imaging research study
Sexes Eligible for Study: Female
25 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
NIH Grant: 5 R44 CA103102-05
Not Provided
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Judith E Kalinyak, Medical Director, Naviscan PET Systems, Inc
Naviscan PET Systems
Certus International, Inc.
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
Naviscan PET Systems
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP