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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Positron Emission Mammography
Magnetic Resonance Imaging
Sponsored by
Naviscan PET Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Breast Cancer, breast conserving surgery

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Southern California
  • Scripps Cancer Center
  • Boca Raton Community Hospital
  • Anne Arundel Medical Center
  • American Radiology Services, Inc., Johns Hopkins Green Spring
  • University of North Carolina School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1 PEM

2 MRI

Arm Description

Outcomes

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.

Secondary Outcome Measures

Risk of false positive examinations with either PEM or MRI imaging with surgery as gold standard

Full Information

First Posted
June 8, 2007
Last Updated
September 2, 2009
Sponsor
Naviscan PET Systems
Collaborators
Certus International, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00484614
Brief Title
Study the Role of Positron Emission Mammography in Pre-surgical Planning for Breast Cancer
Official Title
Prospective Multicenter Study of the Role of Positron Emission Mammography (PEM) in Pre-Surgical Planning for Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2006 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
March 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Naviscan PET Systems
Collaborators
Certus International, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, breast conserving surgery

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
472 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 PEM
Arm Type
Active Comparator
Arm Title
2 MRI
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Mammography
Other Intervention Name(s)
Naviscan PET Systems, PEM Flex Solo
Intervention Description
Molecular Imaging Device
Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Imaging
Intervention Description
Imaging Device
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women who are 25 years of age or older Newly diagnosed core-biopsy proven breast cancer Has current mammography of all study breasts (within prior 3 months), including magnification views of suspicious calcifications (if any) Recent clinical breast examination (within prior 3 months) Has had full diagnostic workup with breast ultrasound (within prior 3 months) as indicated by mammographic and/or clinical findings Has had percutaneous biopsy of all relevant suspicious findings on mammography, clinical examination, and ultrasound After full diagnostic workup, participant is likely to be a candidate for breast conserving surgery. 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. 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 Has signed study-specific consent form Subject agrees to undergo a contrast-enhanced MRI and PEM scan within five business days of each other, prior to surgery. Exclusion Criteria: Male Pregnancy Active lactation or discontinued breastfeeding < 2 months prior Age less than 25 years Inability to provide informed consent Prior radiation treatment to the affected breast(s) Participant is scheduled for sentinel node procedure using radioactive Tc-99m within 24 hours after the scheduled PEM Flex study Women planning prophylactic mastectomy without histologic confirmation 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) Individuals who have had surgery on the study breast(s) within the past 12 months Breast implant(s) in any study breast(s) Women who have had distant metastatic disease either currently or in the past Individuals with Type I or poorly controlled Type II diabetes mellitus Individuals with a blood glucose level that is above 140 mg/dl at the time of PEM imaging Has not had contrast-enhanced breast MRI or PEM within the past 12 months prior to study enrollment Subject is currently enrolled in another breast imaging research study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendie A Berg, MD, Ph.D
Organizational Affiliation
American Radiology Services, Johns Hopkins Greenspring, Lutherville, MD
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Etta Pisano, MD, FACR
Organizational Affiliation
University of North Carolina School of Medicine, Chapel Hill, NC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathy Schilling, MD
Organizational Affiliation
Boca Raton Community Hospital, Boca Raton, FL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marie Tartar, MD
Organizational Affiliation
Scripps Cancer Center, San Diego, CA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Linda Hovanessian Larsen, MD
Organizational Affiliation
USC Norris Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lorraine Tafra, MD
Organizational Affiliation
Anne Arundel Medical Center, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Scripps Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Boca Raton Community Hospital
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Anne Arundel Medical Center
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
American Radiology Services, Inc., Johns Hopkins Green Spring
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
University of North Carolina School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16848840
Citation
Berg WA, Weinberg IN, Narayanan D, Lobrano ME, Ross E, Amodei L, Tafra L, Adler LP, Uddo J, Stein W 3rd, Levine EA; Positron Emission Mammography Working Group. High-resolution fluorodeoxyglucose positron emission tomography with compression ("positron emission mammography") is highly accurate in depicting primary breast cancer. Breast J. 2006 Jul-Aug;12(4):309-23. doi: 10.1111/j.1075-122X.2006.00269.x.
Results Reference
background
PubMed Identifier
16164937
Citation
Tafra L, Cheng Z, Uddo J, Lobrano MB, Stein W, Berg WA, Levine E, Weinberg IN, Narayanan D, Ross E, Beylin D, Yarnall S, Keen R, Sawyer K, Van Geffen J, Freimanis RL, Staab E, Adler LP, Lovelace J, Shen P, Stewart J, Dolinsky S. Pilot clinical trial of 18F-fluorodeoxyglucose positron-emission mammography in the surgical management of breast cancer. Am J Surg. 2005 Oct;190(4):628-32. doi: 10.1016/j.amjsurg.2005.06.029.
Results Reference
background
Links:
URL
http://www.naviscanpet.com
Description
Sponsor's website

Learn more about this trial

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

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