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

September 2, 2009 updated by: Naviscan PET Systems

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

472

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • San Diego, California, United States, 92121
        • Scripps Cancer Center
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Boca Raton Community Hospital
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Medical Center
      • Lutherville, Maryland, United States, 21093
        • American Radiology Services, Inc., Johns Hopkins Green Spring
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1 PEM
Procedure: Positron Emission Mammography
Molecular Imaging Device
Other Names:
  • Naviscan PET Systems, PEM Flex Solo
Active Comparator: 2 MRI
Procedure: Magnetic Resonance Imaging
Imaging Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Within 30 days (plus or minus a week) after core biopsy/surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Within the first 30 days (plus or minus 7 days) after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Naviscan PET Systems

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

November 1, 2008

Study Completion (Anticipated)

March 1, 2009

Study Registration Dates

First Submitted

June 8, 2007

First Submitted That Met QC Criteria

June 8, 2007

First Posted (Estimate)

June 11, 2007

Study Record Updates

Last Update Posted (Estimate)

September 3, 2009

Last Update Submitted That Met QC Criteria

September 2, 2009

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEM-06-01
  • NIH Grant: 5 R44 CA103102-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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