Clinical trial · Interventional
Pilot Study to Evaluate High Resolution PET Image-Guidance for Sampling of Breast Abnormalities
Pilot Clinical Study to Evaluate High Resolution PET Imaging- Guidance for Sampling of Breast Abnormalities in Patients With Known or Suspected Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereo Navigator Accessory to PEM Flex PET Scanner | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- one arm
- interventionNames
- Device: Stereo Navigator Accessory to PEM Flex PET Scanner
Primary outcomes (1)
- measure
- Number of Lesions That Were Successfully Biopsied Using the PET-guided Biopsy Method.
- timeFrame
- within two days of obtaining histopathology of the lesion biopsied
- description
- Success in completion of the PET guided biopsy of a suspicious lesion was determined by 1. Alteration in lesion morphology (no change in vs change in lesion morphology) after sampling AND/OR 2. Visualization of regions with high radioactive uptake within the biopsy specimen consistent with target lesion (focal uptake present vs absent).
Secondary outcomes (1)
- measure
- Number of Participants Who Reported Serious Adverse Events After the PET-Guided Biopsy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKalinyak JE, Schilling K, Berg WA, Narayanan D, Mayberry JP, Rai R, Dupree EB, Shusterman DK, Gittleman MA, Luo W, Matthews CG. PET-guided breast biopsy. Breast J. 2011 Mar-Apr;17(2):143-51. doi: 10.1111/j.1524-4741.2010.01044.x. Epub 2011 Jan 31. PMID 21276128