search
Back to results

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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stereo Navigator Accessory to PEM Flex PET Scanner
Sponsored by
Naviscan PET Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring biopsy, PET, image-guidance, breast cancer, FDG, PEM

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Boca Raton Community Hospital
  • American Radiology Services, Greenspring
  • Epic Imaging
  • Advanced Breast Care Imaging
  • Diversified Specialty Institutes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

one arm

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
January 22, 2008
Last Updated
May 20, 2009
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
search

1. Study Identification

Unique Protocol Identification Number
NCT00606931
Brief Title
Pilot Study to Evaluate High Resolution PET Image-Guidance for Sampling of Breast Abnormalities
Acronym
PEM-BX
Official Title
Pilot Clinical Study to Evaluate High Resolution PET Imaging- Guidance for Sampling of Breast Abnormalities in Patients With Known or Suspected Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
biopsy, PET, image-guidance, breast cancer, FDG, PEM

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
one arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Stereo Navigator Accessory to PEM Flex PET Scanner
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Lesions That Were Successfully Biopsied Using the PET-guided Biopsy Method.
Description
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).
Time Frame
within two days of obtaining histopathology of the lesion biopsied
Secondary Outcome Measure Information:
Title
Number of Participants Who Reported Serious Adverse Events After the PET-Guided Biopsy
Description
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
Time Frame
Within one week of completing PET-guided biopsy
Other Pre-specified Outcome Measures:
Title
Number of Participants Who Tolerated the PET-Guided Biopsy Procedure
Description
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.
Time Frame
Within one week of completing PET-guided biopsy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith E Kalinyak, MD, Ph.D
Organizational Affiliation
Naviscan PET Systems, Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boca Raton Community Hospital
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
American Radiology Services, Greenspring
City
Timonium
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Epic Imaging
City
Portland
State/Province
Oregon
ZIP/Postal Code
97220
Country
United States
Facility Name
Advanced Breast Care Imaging
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Diversified Specialty Institutes
City
Bensalem
State/Province
Pennsylvania
ZIP/Postal Code
37219
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21276128
Citation
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.
Results Reference
derived
Links:
URL
http://www.naviscanpet.com
Description
Website of Study sponsor : Naviscan PET Systems, Inc

Learn more about this trial

Pilot Study to Evaluate High Resolution PET Image-Guidance for Sampling of Breast Abnormalities

We'll reach out to this number within 24 hrs