Trial record 1 of 1 for:    NCT00484614
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Study the Role of Positron Emission Mammography in Pre-surgical Planning for Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Naviscan PET Systems.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Certus International, Inc.
Information provided by:
Naviscan PET Systems
ClinicalTrials.gov Identifier:
NCT00484614
First received: June 8, 2007
Last updated: September 2, 2009
Last verified: December 2008
  Purpose

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
Breast Cancer
Procedure: Positron Emission Mammography
Procedure: Magnetic Resonance Imaging
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Prospective Multicenter Study of the Role of Positron Emission Mammography (PEM) in Pre-Surgical Planning for Breast Cancer

Resource links provided by NLM:


Further study details as provided by Naviscan PET Systems:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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
Active Comparator: 1 PEM Procedure: Positron Emission Mammography
Molecular Imaging Device
Other Name: Naviscan PET Systems, PEM Flex Solo
Active Comparator: 2 MRI Procedure: Magnetic Resonance Imaging
Imaging Device

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484614

Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033
Scripps Cancer Center
San Diego, California, United States, 92121
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
Sponsors and Collaborators
Naviscan PET Systems
Certus International, Inc.
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: Judith E Kalinyak, Medical Director, Naviscan PET Systems, Inc
ClinicalTrials.gov Identifier: NCT00484614     History of Changes
Other Study ID Numbers: PEM-06-01, NIH Grant: 5 R44 CA103102-05
Study First Received: June 8, 2007
Last Updated: September 2, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Naviscan PET Systems:
Breast Cancer, breast conserving surgery

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 22, 2014