Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Diseases and Abnormalities at or Before Birth

Breast Neoplasms

Congenital Abnormalities

Breast Diseases

Skin Diseases

For patients with suspicious breast abnormalities seen on high resolution PET image, the patients will be biopsied using commercial vacuum biopsy devices (pre-validated to work with Stereo Navigator) using Naviscan's Stereo Navigator (interventional device) for PET image guidance.

Stereo Navigator Accessory to PEM Flex PET Scanner

Judith E Kalinyak, MD, Ph.D

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)

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.

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

Participants who could tolerate the procedure and complete it. This was ascertained by patient feedback questionnaire asking for overall discomfort rating from 0 to 5, where 0 is no discomfort and 5 was assigned to acute discomfort that prevented subject from completing the procedure.

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).

Serious Adverse Events are defined as events that

* Are fatal or life-threatening
* Require in-patient hospitalization or prolong hospitalization
* Result in permanent or significant disability/incapacity
* Result in congenital abnormality/birth defect

American Radiology Services, Inc

Boca Raton community Hospital, FL

Diversified Specialty Institutes, Bensalem, PA

Advanced Breast Care Imaging

Epic Imaging

Naviscan PET Systems

Judith Kalinyak, MD. Ph.D, Medical Director

No comparison group. All enrolled participants were expected to undergo PET guided biopsy.

PET Guided Biopsy

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Judith E Kalinyak, MD, PhD, Medical Director

All participants who completed the PET-guided biopsy for a suspicious lesions. 24 lesions were biopsied in 19 participants

Spots Global Cancer Trial Database for stereo navigator accessory to pem flex pet scanner