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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00484614
• Other study ID #: PEM-06-01
• Secondary ID: NIH Grant: 5 R44
• Status: Active, not recruiting
• Phase: Phase 4
• First received: June 8, 2007
• Last updated: September 2, 2009
• Start date: September 2006
• Est. completion date: March 2009

Study information

• Verified date: December 2008
• Source: Naviscan PET Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 472
• Est. completion date: March 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Positron Emission Mammography
Molecular Imaging Device
• Magnetic Resonance Imaging
Imaging Device

Locations

Country	Name	City	State
United States	Anne Arundel Medical Center	Annapolis	Maryland
United States	Boca Raton Community Hospital	Boca Raton	Florida
United States	University of North Carolina School of Medicine	Chapel Hill	North Carolina
United States	University of Southern California	Los Angeles	California
United States	American Radiology Services, Inc., Johns Hopkins Green Spring	Lutherville	Maryland
United States	Scripps Cancer Center	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Naviscan PET Systems	Certus International, Inc.

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

•   Sponsor's website