Clinical trial NCT00484614: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Breast Cancer
Keywords: Breast Cancer, breast conserving surgery
Lead sponsor: Naviscan PET Systems
Sponsor class: INDUSTRY
Collaborators: name: Certus International, Inc.
First posted: 2007-06-11
Enrollment: 472
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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).

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

Primary outcomes:
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.
timeFrame: Within 30 days (plus or minus a week) after core biopsy/surgery
Secondary outcomes:
measure: Risk of false positive examinations with either PEM or MRI imaging with surgery as gold standard
timeFrame: Within the first 30 days (plus or minus 7 days) after surgery
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: San Diego
country: United States
facility: Scripps Cancer Center
state: California
city: Boca Raton
country: United States
facility: Boca Raton Community Hospital
state: Florida
city: Annapolis
country: United States
facility: Anne Arundel Medical Center
state: Maryland
city: Lutherville
country: United States
facility: American Radiology Services, Inc., Johns Hopkins Green Spring
state: Maryland
city: Chapel Hill
country: United States
facility: University of North Carolina School of Medicine
state: North Carolina
Study officials:
affiliation: American Radiology Services, Johns Hopkins Greenspring, Lutherville, MD
name: Wendie A Berg, MD, Ph.D
role: STUDY_DIRECTOR
affiliation: University of North Carolina School of Medicine, Chapel Hill, NC
name: Etta Pisano, MD, FACR
role: PRINCIPAL_INVESTIGATOR
affiliation: Boca Raton Community Hospital, Boca Raton, FL
name: Kathy Schilling, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Scripps Cancer Center, San Diego, CA
name: Marie Tartar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: USC Norris Cancer Center
name: Linda Hovanessian Larsen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anne Arundel Medical Center, MD
name: Lorraine Tafra, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.