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

NCT ID: NCT00484614

Last Updated: 2009-09-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 472 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2009-03-31

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).

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

1 PEM

Group Type: ACTIVE_COMPARATOR

Positron Emission Mammography

Intervention Type: PROCEDURE

Molecular Imaging Device

2 MRI

Group Type: ACTIVE_COMPARATOR

Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Imaging Device

Interventions

Positron Emission Mammography

Molecular Imaging Device

Intervention Type: PROCEDURE

Magnetic Resonance Imaging

Imaging Device

Intervention Type: PROCEDURE

Other Intervention Names

Naviscan PET Systems, PEM Flex Solo

Eligibility 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

• Minimum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Certus International, Inc.

OTHER

Sponsor Role: collaborator

Naviscan PET Systems

INDUSTRY

Sponsor Role: lead

Responsible Party

Naviscan PET Systems, Inc

Principal Investigators

Wendie A Berg, MD, Ph.D

Role: STUDY_DIRECTOR

American Radiology Services, Johns Hopkins Greenspring, Lutherville, MD

Etta Pisano, MD, FACR

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina School of Medicine, Chapel Hill, NC

Kathy Schilling, MD

Role: PRINCIPAL_INVESTIGATOR

Boca Raton Community Hospital, Boca Raton, FL

Marie Tartar, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Cancer Center, San Diego, CA

Linda Hovanessian Larsen, MD

Role: PRINCIPAL_INVESTIGATOR

USC Norris Cancer Center

Lorraine Tafra, MD

Role: PRINCIPAL_INVESTIGATOR

Anne Arundel Medical Center, MD

Locations

University of Southern California

Los Angeles, California, United States

Scripps Cancer Center

San Diego, California, United States

Boca Raton Community Hospital

Boca Raton, Florida, United States

Anne Arundel Medical Center

Annapolis, Maryland, United States

American Radiology Services, Inc., Johns Hopkins Green Spring

Lutherville, Maryland, United States

University of North Carolina School of Medicine

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 16848840 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16164937 (View on PubMed)

Related Links

http://www.naviscanpet.com

Sponsor's website

Other Identifiers

NIH Grant: 5 R44 CA103102-05

Identifier Type: -

Identifier Source: secondary_id

PEM-06-01

Identifier Type: -

Identifier Source: org_study_id