Pilot Study to Evaluate High Resolution PET Image-Guidance for Sampling of Breast Abnormalities (PEM-BX)

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

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)

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Stereo Navigator Accessory to PEM Flex PET Scanner

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 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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: one arm	Device: Stereo Navigator Accessory to PEM Flex PET Scanner; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Lesions That Were Successfully Biopsied Using the PET-guided Biopsy Method.	Success in completion of the PET guided biopsy of a suspicious lesion was determined by; Alteration in lesion morphology (no change in vs change in lesion morphology) after sampling AND/OR; Visualization of regions with high radioactive uptake within the biopsy specimen consistent with target lesion (focal uptake present vs absent).	within two days of obtaining histopathology of the lesion biopsied

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Reported Serious Adverse Events After the PET-Guided Biopsy	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	Within one week of completing PET-guided biopsy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Tolerated the PET-Guided Biopsy Procedure	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.	Within one week of completing PET-guided biopsy

Collaborators and Investigators

• Sponsor: Naviscan PET Systems
• Collaborators: American Radiology Services, Inc; Boca Raton community Hospital, FL; Diversified Specialty Institutes, Bensalem, PA; Advanced Breast Care Imaging; Epic Imaging
• Investigators: Principal Investigator: Judith E Kalinyak, MD, Ph.D, Naviscan PET Systems, Inc

Publications and helpful links

General Publications

• Kalinyak 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.

Helpful Links

• Website of Study sponsor : Naviscan PET Systems, Inc

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: January 22, 2008
• First Submitted That Met QC Criteria: February 4, 2008
• First Posted (Estimate): February 5, 2008

Study Record Updates

• Last Update Posted (Estimate): July 7, 2009
• Last Update Submitted That Met QC Criteria: May 20, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: breast cancer; PET; FDG; biopsy; PEM; image-guidance
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PEM-07-02; NIH/NCI 5 R44 CA082042-03