Status:
COMPLETED
Pilot Study to Evaluate High Resolution PET Image-Guidance for Sampling of Breast Abnormalities
Lead Sponsor:
Naviscan PET Systems
Collaborating Sponsors:
American Radiology Services, Inc
Boca Raton community Hospital, FL
Conditions:
Breast Cancer
Eligibility:
FEMALE
25+ years
Phase:
NA
Brief Summary
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 iden...
Detailed Description
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 malignan...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00606931
Start Date
January 1 2008
End Date
August 1 2008
Last Update
July 7 2009
Active Locations (5)
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1
Boca Raton Community Hospital
Boca Raton, Florida, United States, 33486
2
American Radiology Services, Greenspring
Timonium, Maryland, United States, 21093
3
Epic Imaging
Portland, Oregon, United States, 97220
4
Advanced Breast Care Imaging
Allentown, Pennsylvania, United States, 18104