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Pilot Clinical Study to Evaluate High Resolution PET Imaging- Guidance for Sampling of Breast Abnormalities in Patients With Known or Suspected Breast Cancer

25 Years
Not Enrolling
Breast Cancer

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Trial Information

Pilot Clinical Study to Evaluate High Resolution PET Imaging- Guidance for Sampling of Breast Abnormalities in Patients With Known or Suspected Breast Cancer

The study will invite participation from human subjects with newly diagnosed or suspected
breast cancer who have one or more breast abnormalities moderately suspicious or highly
suggestive of malignancy on breast imaging and requiring biopsy (the lesion(s) of interest).
Prospective subjects will be asked to sign IRB-approved consent forms, explaining the use of
PET imaging for guiding biopsy of suspicious lesion(s). Up to 30 patients will be recruited
in the study. The study will be terminated after approximately 20 subjects undergo
PET-guided interventional procedures. In the course of the study, a subject will be injected
with 18F-FDG and imaged using the PEM Flex PET scanner. Once an abnormality requiring biopsy
is identified on the PET scan, the physician conducting the procedure will use the PET image
to plan the biopsy trajectory using the Stereo Navigator Software Module, and use the Stereo
Navigator Needle Guide Holder to guide insertion of the introducing stylet toward the
lesion. The sampling will be performed using commercially available core biopsy tools
routinely used for MRI-guided biopsy.Immediately after the PET-guided biopsy, conventional
biopsy markers will be inserted at the biopsy site(s) for correlation with other imaging
modalities. Placement of the biopsy marker will be documented using mammography, as per
standard clinical practice. Histopathologic results will be correlated with imaging
findings. The procedure may be repeated for additional lesions identified on PET at the
investigator's discretion.

Inclusion Criteria:

Individuals aged 25 years or older

- Individuals who have at least one breast imaging finding requiring biopsy,

- 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

- Individuals who have agreed to participate in the study and who have signed
study-specific informed consent

Exclusion Criteria:

- 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

- Inability to provide informed consent

- Individuals who have had surgery on the study breast(s) within the past 12 months

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Number of Lesions That Were Successfully Biopsied Using the PET-Guided Biopsy Method.

Outcome Time Frame:

within two days of obtaining histopathology of the lesion biopsied

Safety Issue:


Principal Investigator

Judith E Kalinyak, MD, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Naviscan PET Systems, Inc


United States: Institutional Review Board

Study ID:




Start Date:

January 2008

Completion Date:

August 2008

Related Keywords:

  • Breast Cancer
  • biopsy
  • PET
  • image-guidance
  • breast cancer
  • FDG
  • PEM
  • Congenital Abnormalities
  • Breast Neoplasms



Boca Raton Community Hospital Boca Raton, Florida  33486
American Radiology Services, Greenspring Timonium, Maryland  21093
Epic Imaging Portland, Oregon  97220
Advanced Breast Care Imaging Allentown, Pennsylvania  18104
Diversified Specialty Institutes Bensalem, Pennsylvania  37219