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

• ClinicalTrials.gov Identifier: NCT00484614
• Recruitment Status: Unknown
• First Posted: June 11, 2007
• Last Update Posted: September 3, 2009
• Sponsor: Naviscan PET Systems
• Collaborator: Certus International, Inc.
• Information provided by: Naviscan PET Systems

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Procedure: Positron Emission Mammography; Procedure: Magnetic Resonance Imaging	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 472 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Primary Purpose: Diagnostic
• Official Title: Prospective Multicenter Study of the Role of Positron Emission Mammography (PEM) in Pre-Surgical Planning for Breast Cancer
• Study Start Date: September 2006
• Actual Primary Completion Date: November 2008
• Estimated Study Completion Date: March 2009

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 25 Years and older (Adult, Older Adult)
• Sexes 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

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:

Sponsor's website 

Publications:

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.

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.

• Responsible Party: Judith E Kalinyak, Medical Director, Naviscan PET Systems, Inc
• ClinicalTrials.gov Identifier: NCT00484614
• Other Study ID Numbers: PEM-06-01; NIH Grant: 5 R44 CA103102-05
• First Posted: June 11, 2007
• Last Update Posted: September 3, 2009
• Last Verified: December 2008

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