Breast CancerNCT00981812
Positron Emission Mammography (PEM) Biopsy Accessory for the Diagnosis of Breast Cancer
A study testing PEM Breast Biopsy in people with Breast Cancer, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate how well the Stereo Navigator Biopsy Accessory for the PEM Flex solo II PET Scanner works for performing breast biopsy on suspicious lesions. 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?
- PEM Breast Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Apr 2012
- 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
- female
- subject is 25-100 years of age
- subjects has at least one breast imaging finding on mammography and/or ultrasound which is assessed as highly suggestive of malignancy and recommended to biopsy
- subject is able to provide informed consent
Who cannot join
- subject is pregnant
- subject is actively lactating or discontinued breastfeeding less than 2 months ago
- subject has breast implants
- subject is scheduled for sentinel node procedure using radioactive Tc-99m within 24 hours of the PEM study
- subject has contraindications for core biopsy and other invasive procedures
- subject has Type I diabetes mellitus or poorly controlled Type II diabetes mellitus
- subject has had surgery or radiation therapy on the study breast or has had chemotherapy within the past 12 months
- subject has not fasted for 4-6 hours prior to the procedure and/or have a fasting blood glucose level greater than 140 mg/dl on day of PEM imaging
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Hospital, The Barrett Center
Cincinnnati, Ohio, 45219
About this study
Official title: Clinical Utility and Initial Experience With PEM Flex Solo II PET Scanner and Stereo Navigator Biopsy Accessory for the Diagnosis of Breast Cancer
The purpose of this research study is to evaluate how well the Stereo Navigator Biopsy Accessory for the PEM Flex solo II PET Scanner works for performing breast biopsy on suspicious lesions. This study will also allow the doctors to describe the features of PEM detected lesions and the results obtained using the PEM guided biopsy and will compare the time it took to complete a pre-operative work up using PEM versus MRI in patients with a suspicious breast lesion resulting in cancer.
Read the detailed description
See brief summary.
- Conditions
- Breast Cancer
- Being tested
- PEM Breast Biopsy
- Keywords
- PET, PEM, Positron Emission Mammography, Breast Biopsy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEM Breast BiopsyProcedure or surgery
Also called Naviscan PEM 2400 Pet Scanner, Stereo Navigator Accessory
Breast biopsy using PEM guidance and Stereo Navigator software
| Study group | Role | What they receive |
|---|---|---|
| PEM Breast Biopsy | Experimental | All patients underwent PEM biopsy. Receives: Procedure: PEM Breast Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day.
Measured: At time of biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2011
- Study completionApr 2012
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.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Mahoney, University of Cincinnati
- Investigators
- Mary C Mahoney, MD, Principal investigator, Univeristy of CincinnatiAmy Argus, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981812
- Sponsor's protocol ID
- Cincinnati-01
- Status last verified
- Mar 2016
- First submitted
- 18 Sep 2009
- Last updated
- 4 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility and Initial Experience With PEM Flex Solo II PET Scanner and Stereo Navigator Biopsy Accessory for the Diagnosis of Breast Cancer
- ClinicalTrials.gov ID
- NCT00981812
- Acronym / sponsor ID
- Cincinnati-01
- Conditions
- Breast Cancer
- Keywords
- PET, PEM, Positron Emission Mammography, Breast Biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Posted 4 Apr 2016
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 research study is to evaluate how well the Stereo Navigator Biopsy Accessory for the PEM Flex solo II PET Scanner works for performing breast biopsy on suspicious lesions. This study will also allow the doctors to describe the features of PEM detected lesions and the results obtained using the PEM guided biopsy and will compare the time it took to complete a pre-operative work up using PEM versus MRI in patients with a suspicious breast lesion resulting in cancer.
Detailed description
See brief summary.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEM Breast Biopsy | Experimental | Procedure: PEM Breast BiopsyAll patients underwent PEM biopsy. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- female
- subject is 25-100 years of age
- subjects has at least one breast imaging finding on mammography and/or ultrasound which is assessed as highly suggestive of malignancy and recommended to biopsy
- subject is able to provide informed consent
Key exclusion criteria (8 listed)
- subject is pregnant
- subject is actively lactating or discontinued breastfeeding less than 2 months ago
- subject has breast implants
- subject is scheduled for sentinel node procedure using radioactive Tc-99m within 24 hours of the PEM study
- subject has contraindications for core biopsy and other invasive procedures
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 |
|---|---|---|
| PEM Breast BiopsyAlso: Naviscan PEM 2400 Pet Scanner, Stereo Navigator AccessoryBreast biopsy using PEM guidance and Stereo Navigator software | Procedure or surgery | PEM Breast Biopsy |
Primary outcome
Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day.
Time frame: At time of biopsy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mary C Mahoney, MD principal investigator
Univeristy of Cincinnati
Amy Argus, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEM Breast Biopsy in people with Breast Cancer, run by University of Cincinnati at 1 site 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 4 inclusion and 8 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 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 4 Apr 2016). 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?
Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day. (time frame: At time of biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2016.