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

NCT00484614 | Unknown Phase 4 DMC

• 2 other identifiers: PEM-06-01NIH Grant: 5 R44 CA103102-05
• Study Type: interventional
• Target: 472
• Locations: 1 country
• Sites: 6

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.

Conditions

Breast Cancer

Keywords

Breast Cancer, breast conserving surgery

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

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

  Within the first 30 days (plus or minus 7 days) after surgery

Study Arms (2)

1 PEM

ACTIVE COMPARATOR

Procedure: Positron Emission Mammography

2 MRI

ACTIVE COMPARATOR

Procedure: Magnetic Resonance Imaging

Interventions

Positron Emission Mammography PROCEDURE

Molecular Imaging Device

Also known as: Naviscan PET Systems, PEM Flex Solo

1 PEM

Magnetic Resonance Imaging PROCEDURE

Imaging Device

2 MRI

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Naviscan PET Systems: lead
• Certus International, Inc.: collaborator

Study Sites (6)

University of Southern California

Los Angeles, California, 90033, United States

Location

Scripps Cancer Center

San Diego, California, 92121, United States

Location

Boca Raton Community Hospital

Boca Raton, Florida, 33486, United States

Location

Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

American Radiology Services, Inc., Johns Hopkins Green Spring

Lutherville, Maryland, 21093, United States

Location

University of North Carolina School of Medicine

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (2)

• 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.

  PMID: 16848840 BACKGROUND

• 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.

  PMID: 16164937 BACKGROUND

Related Links

• Sponsor's website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Wendie A Berg, MD, Ph.D

  American Radiology Services, Johns Hopkins Greenspring, Lutherville, MD

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 8, 2007
• First Posted: June 11, 2007
• Study Start: September 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: March 1, 2009
• Last Updated: September 3, 2009

Record last verified: 2008-12

Locations

US (6)