Breast CancerNCT01012440
Role of Positron Emission Mammography (PEM) Flex Solo II Positron Emission Tomography (PET) Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer
A study testing PEM Flex Solo II PET Scanner and MRI scan in people with Breast Cancer, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is: 1. To evaluate the hypothesis: Can PEM Flex Solo II PET scanner ascertain response to neoadjuvant chemotherapy in patients with breast cancer? 2. To compare the results from the PEM Flex Solo II PET scanner to the standard of care bilateral breast MRI. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- PEM Flex Solo II PET Scanner and MRI scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to May 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 18-75 years old with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e., lumpectomy)
Who cannot join
- Children (< 18 years old)
- Pregnant or Lactating women
- Diabetic patients (Type I or II)
- Patients who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of PEM
- Patients who have NOT undergone a standard of care bilateral breast MRI
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: Role of PEM Flex Solo II PET Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer
The purpose of this study is:
- To evaluate the hypothesis: Can PEM Flex Solo II PET scanner ascertain response to neoadjuvant chemotherapy in patients with breast cancer?
- To compare the results from the PEM Flex Solo II PET scanner to the standard of care bilateral breast MRI.
Read the detailed description
Subjects will receive bilateral (both sides) breast and axillary PEM scans. All recruited subjects chosen for the study will have biopsy proven breast cancer and are eligible for chemotherapy. They will undergo bilateral breast MRI for staging which is considered standard of care. Breast MRI and PEM scans will be performed at at baseline (phase 0 or pre-operative phase), 2nd MRI and PEM after 1 to 2 weeks of NAC (phase 1) and 3rd MRI and PEM after 1 to 2 weeks of phase 1 (phase 2). DCE-MRI and PEM will be performed not more than 14 days apart within each phase. Cranio-Caudal (CC) and Medial Lateral Oblique (MLO) PEM views will be performed of both the ipsilateral and contralateral breast and axillae by a Mammography Technologist trained in mammographic positioning.
- Conditions
- Breast Cancer
- Being tested
- PEM Flex Solo II PET Scanner, MRI scan
- 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 Flex Solo II PET ScannerDevice
Subjects will receive bilateral (both sides) breast and axillary PEM scans.
MRI scanDevice
Subjects will receive bilateral (both sides) breast and axillary MRI scans.
| Study group | Role | What they receive |
|---|---|---|
| Beast cancer subjects | Experimental | Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods Receives: Device: PEM Flex Solo II PET Scanner; Device: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Tumor Size
Comparison of tumor size pre chemotherapy and post chemotherapy represents the PEM data. There is no the response with MRI because the study was aborted and very few patients were involved.
Measured: 1-2 weeks post treatment onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionMay 2011
- Study completionMay 2012
Why it stopped: Poor accrual
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 ChicagoThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kirti Kulkarni, M.D., Principal investigator, The University of Chicago Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012440
- Sponsor's protocol ID
- 16895A
- Status last verified
- Jun 2015
- First submitted
- 25 Jun 2009
- Last updated
- 27 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of PEM Flex Solo II PET Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT01012440
- Acronym / sponsor ID
- 16895A
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 13 Nov 2009 (estimated)
- Results
- Posted 27 Jul 2015
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 study is:
- To evaluate the hypothesis: Can PEM Flex Solo II PET scanner ascertain response to neoadjuvant chemotherapy in patients with breast cancer?
- To compare the results from the PEM Flex Solo II PET scanner to the standard of care bilateral breast MRI.
Detailed description
Subjects will receive bilateral (both sides) breast and axillary PEM scans. All recruited subjects chosen for the study will have biopsy proven breast cancer and are eligible for chemotherapy. They will undergo bilateral breast MRI for staging which is considered standard of care. Breast MRI and PEM scans will be performed at at baseline (phase 0 or pre-operative phase), 2nd MRI and PEM after 1 to 2 weeks of NAC (phase 1) and 3rd MRI and PEM after 1 to 2 weeks of phase 1 (phase 2). DCE-MRI and PEM will be performed not more than 14 days apart within each phase. Cranio-Caudal (CC) and Medial Lateral Oblique (MLO) PEM views will be performed of both the ipsilateral and contralateral breast and axillae by a Mammography Technologist trained in mammographic positioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Beast cancer subjects | Experimental | Device: PEM Flex Solo II PET Scanner, Device: MRI scanSubject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women 18-75 years old with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e., lumpectomy)
Key exclusion criteria (5 listed)
- Children (< 18 years old)
- Pregnant or Lactating women
- Diabetic patients (Type I or II)
- Patients who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of PEM
- Patients who have NOT undergone a standard of care bilateral breast MRI
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 Flex Solo II PET ScannerSubjects will receive bilateral (both sides) breast and axillary PEM scans. | Device | Beast cancer subjects |
| MRI scanSubjects will receive bilateral (both sides) breast and axillary MRI scans. | Device | Beast cancer subjects |
Primary outcome
Reduction in Tumor Size
Time frame: 1-2 weeks post treatment onset
Comparison of tumor size pre chemotherapy and post chemotherapy represents the PEM data. There is no the response with MRI because the study was aborted and very few patients were involved.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
- 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.
Kirti Kulkarni, M.D. principal investigator
The University of Chicago Medical Center
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 Flex Solo II PET Scanner and MRI scan in people with Breast Cancer, run by University of Chicago 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 1 inclusion and 5 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: stopped early, as of the sponsor's last update on 27 Jul 2015. 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 27 Jul 2015). 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?
Reduction in Tumor Size (time frame: 1-2 weeks post treatment onset). 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 27 Jul 2015.