Breast CancerPEM-BXNCT00606931
Pilot Study to Evaluate High Resolution PET Image-Guidance for Sampling of Breast Abnormalities
A study testing Stereo Navigator Accessory to PEM Flex PET Scanner in people with Breast Cancer, run by Naviscan PET Systems at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Stereo Navigator Accessory to PEM Flex PET Scanner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2008to Aug 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Advanced Breast Care Imaging
Allentown, Pennsylvania, 18104
Diversified Specialty Institutes
Bensalem, Pennsylvania, 37219
Boca Raton Community Hospital
Boca Raton, Florida, 33486
Epic Imaging
Portland, Oregon, 97220
American Radiology Services, Greenspring
Timonium, Maryland, 21093
About this study
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
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)
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Stereo Navigator Accessory to PEM Flex PET Scanner
- Keywords
- biopsy, PET, image-guidance, breast cancer, FDG, PEM
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| one arm | Experimental | Not described Receives: Device: Stereo Navigator Accessory to PEM Flex PET Scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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
Measured: Within one week of completing PET-guided biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Naviscan PET Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- American Radiology Services, Inc, Boca Raton Regional Hospital, Diversified Specialty Institutes, Bensalem, PA, Advanced Breast Care Imaging, Epic Imaging
- Investigators
- Judith E Kalinyak, MD, Ph.D, Principal investigator, Naviscan PET Systems, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606931
- Sponsor's protocol ID
- PEM-07-02
- Other IDs
- NIH/NCI 5 R44 CA082042-03
- Acronym
- PEM-BX
- Status last verified
- May 2009
- First submitted
- 22 Jan 2008
- Last updated
- 7 Jul 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 21276128
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00606931
- Acronym / sponsor ID
- PEM-BX / PEM-07-02
- Conditions
- Breast Cancer
- Keywords
- biopsy, PET, image-guidance, breast cancer, FDG, PEM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Naviscan PET SystemsIndustry (pharma, biotech, devices)
- Collaborators
- American Radiology Services, Inc, Boca Raton Regional Hospital, Diversified Specialty Institutes, Bensalem, PA, Advanced Breast Care Imaging, Epic Imaging
- Study start
- Jan 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 5 Feb 2008 (estimated)
- Results
- Posted 7 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one arm | Experimental | Device: Stereo Navigator Accessory to PEM Flex PET Scanner |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals aged 25 years or older
- Individuals who have at least one breast imaging finding requiring biopsy, specifically:
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereo Navigator Accessory to PEM Flex PET ScannerFor 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. | Device | one arm |
Primary outcome
Number of Lesions That Were Successfully Biopsied Using the PET-guided Biopsy Method.
Time frame: within two days of obtaining histopathology of the lesion biopsied
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).
1 secondary outcome
Number of Participants Who Reported Serious Adverse Events After the PET-Guided Biopsy
Time frame: Within one week of completing PET-guided biopsy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21276128Kalinyak 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.
- Website of Study sponsor : Naviscan PET Systems, IncLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith E Kalinyak, MD, Ph.D principal investigator
Naviscan PET Systems, Inc
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereo Navigator Accessory to PEM Flex PET Scanner in people with Breast Cancer, run by Naviscan PET Systems at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Lesions That Were Successfully Biopsied Using the PET-guided Biopsy Method. (time frame: within two days of obtaining histopathology of the lesion biopsied). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00606931, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2009.