Pilot Study to Evaluate High Resolution PET Image-Guidance for Sampling of Breast Abnormalities

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

The purpose of this pilot clinical study is to test a methodology for using high-resolution Positron Emission Tomography (PET) imaging to guide vacuum-assisted core biopsy of breast abnormalities identified on PET. In order to implement the PET guidance, the study uses the Stereo Navigator accessory to the high-resolution organ-specific PET scanner (PEM Flex™ PET Scanner, Naviscan PET Systems, Inc., San Diego, CA). The Stereo Navigator is an investigational device intended for guiding biopsy needles toward lesions in breasts identified by a physician on a high resolution PET image. The study will evaluate the clinical utility of the Stereo Navigator in guiding the vacuum-assisted core biopsy of breast abnormalities, following the example of prior studies of breast biopsy guided by magnetic resonance imaging (MRI)

Key facts

Study ID

NCT00606931

Run by

Naviscan PET Systems

People needed

22

Starts

2008-01-01

Expected to finish

2008-08-01

Last updated by the study team

2009-07-07

Who can join

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

You may qualify if…

• Individuals aged 25 years or older
• Individuals who have at least one breast imaging finding requiring biopsy, specifically:
• Individuals who have a breast abnormality(ies) moderately suspicious for or highly suggestive of malignancy on imaging with mammography, ultrasound, or MRI (as per ACR BIRADS™ 4C or 5) and requiring biopsy confirmation OR o Individuals with known breast cancer who have additional imaging abnormality(ies) suspicious for malignancy detected on a high-resolution FDG PET scan
• Individuals who had recent conventional imaging work-up including x-ray mammography of the breast containing the abnormality of interest.
• Individuals with suspected tumor size measuring one cm or less on mammography and/or ultrasound and/or MRI if the lesion is visible on any of these modalities, except that each site may enroll up to three patients each where the lesion of interest as measured on mammography (or ultrasound and/or MRI if not detectable on mammography) is more than 1 cm. (Note: The study will target patient enrollment such that at least 50% of the lesions to undergo biopsy across all sites will be less than 1 cm in diameter as measured on mammography, or as measured by other modalities, such as ultrasound, CT, or MRI, if the lesion is not detectable or measurable on mammography.)
• Individuals who have agreed to participate in the study and who have signed study-specific informed consent

You may not qualify if…

• Women who are or may be pregnant
• Women who are currently lactating or discontinued breastfeeding < 2 months prior to the study
• Age less than 25 years
• Individuals with breast implant(s) in the breast containing the lesion of interest
• Individuals who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of PET-guided biopsy
• Patients with contraindications for core biopsy and other invasive procedures such as blood coagulation disorders, infection, or who are unwilling to discontinue use of anticoagulant medication prior to the procedure
• 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
• Inability to provide informed consent
• Individuals who have had surgery on the study breast(s) within the past 12 months

Where it is running

• Boca Raton Community Hospital — Boca Raton, Florida, United States
• American Radiology Services, Greenspring — Timonium, Maryland, United States
• Epic Imaging — Portland, Oregon, United States
• Advanced Breast Care Imaging — Allentown, Pennsylvania, United States
• Diversified Specialty Institutes — Bensalem, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.