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

Status unconfirmed · Phase 4

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00484614

Run by

Naviscan PET Systems

People needed

472

Starts

2006-09-01

Expected to finish

2009-03-01

Last updated by the study team

2009-09-03

Who can join

Age: 25 and older. Sex: female. Healthy volunteers: not accepted.

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
• Subject agrees to undergo a contrast-enhanced MRI and PEM scan within five business days of each other, prior to surgery.

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
• Subject is currently enrolled in another breast imaging research study

Where it is running

• 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

Full record on ClinicalTrials.gov

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