NCT00606931

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2008

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 5, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
11 months until next milestone

Results Posted

Study results publicly available

July 7, 2009

Completed
Last Updated

July 7, 2009

Status Verified

May 1, 2009

Enrollment Period

6 months

First QC Date

January 22, 2008

Results QC Date

March 27, 2009

Last Update Submit

May 20, 2009

Conditions

Breast Cancer

Keywords

biopsyPETimage-guidancebreast cancerFDGPEM

Outcome Measures

Primary Outcomes (1)

  • 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 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).

    within two days of obtaining histopathology of the lesion biopsied

Secondary Outcomes (1)

  • Number of Participants Who Reported Serious Adverse Events After the PET-Guided Biopsy

    Within one week of completing PET-guided biopsy

Other Outcomes (1)

  • Number of Participants Who Tolerated the PET-Guided Biopsy Procedure

    Within one week of completing PET-guided biopsy

Study Arms (1)

one arm

EXPERIMENTAL
Device: Stereo Navigator Accessory to PEM Flex PET Scanner

Interventions

Stereo Navigator Accessory to PEM Flex PET ScannerDEVICE

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.

one arm

Eligibility Criteria

Age25 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Boca Raton Community Hospital

Boca Raton, Florida, 33486, United States

Location

American Radiology Services, Greenspring

Timonium, Maryland, 21093, United States

Location

Epic Imaging

Portland, Oregon, 97220, United States

Location

Advanced Breast Care Imaging

Allentown, Pennsylvania, 18104, United States

Location

Diversified Specialty Institutes

Bensalem, Pennsylvania, 37219, United States

Location

Related Publications (1)

  • 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.

    PMID: 21276128DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Judith E Kalinyak, MD, PhD, Medical Director
Organization
Naviscan Inc
jkalinyak@naviscan.com
858-587-3641

Study Officials

  • Judith E Kalinyak, MD, Ph.D

    Naviscan PET Systems, Inc

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 22, 2008

First Posted

February 5, 2008

Study Start

January 1, 2008

Primary Completion

July 1, 2008

Study Completion

August 1, 2008

Last Updated

July 7, 2009

Results First Posted

July 7, 2009

Record last verified: 2009-05

Locations

US(5)