N/A
N=22
Pilot Study to Evaluate High Resolution PET Image-Guidance for Sampling of Breast Abnormalities
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00606931 ↗Enrolled (actual)
22
Serious AEs
—
Results posted
Jul 2009
Primary outcome: Primary: Number of Lesions That Were Successfully Biopsied Using the PET-guided Biopsy Method. — 24 Number of lesions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stereo Navigator Accessory to PEM Flex PET Scanner (Device)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- Female
- Sponsor
- Naviscan PET Systems
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Lesions That Were Successfully Biopsied Using the PET-guided Biopsy Method. |
24 | — |
| SECONDARY Number of Participants Who Reported Serious Adverse Events After the PET-Guided Biopsy |
— | — |
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 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)
Eligibility Criteria
Inclusion Criteria
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 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 imaging
- Inability to provide informed consent
- Individuals who have had surgery on the study breast(s) within the past 12 months
Data sourced from ClinicalTrials.gov (NCT00606931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.