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Prospective Multicenter Study of the Role of Positron Emission Mammography (PEM) in Pre-Surgical Planning for Breast Cancer

Phase 4
25 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Prospective Multicenter Study of the Role of Positron Emission Mammography (PEM) in Pre-Surgical Planning for Breast Cancer

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

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

- 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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

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.

Outcome Time Frame:

Within 30 days (plus or minus a week) after core biopsy/surgery

Safety Issue:


Principal Investigator

Wendie A Berg, MD, Ph.D

Investigator Role:

Study Director

Investigator Affiliation:

American Radiology Services, Johns Hopkins Greenspring, Lutherville, MD


United States: Institutional Review Board

Study ID:




Start Date:

September 2006

Completion Date:

March 2009

Related Keywords:

  • Breast Cancer
  • Breast Cancer, breast conserving surgery
  • Breast Neoplasms



Anne Arundel Medical Center Annapolis, Maryland  21401
Scripps Cancer Center La Jolla, California  92037
Boca Raton Community Hospital Boca Raton, Florida  33486
University of Southern California Los Angeles, California  90033
American Radiology Services, Inc., Johns Hopkins Green Spring Lutherville, Maryland  21093
University of North Carolina School of Medicine Chapel Hill, North Carolina  27599