Breast CancerMRI-PEMNCT02426489
Improving Diagnosis of Breast Cancer by Using a Combined MRI and Positron Emission Mammography (MRI-PEM) System
A study testing MRI + PEM image in people with Breast Cancer, run by Weinberg Medical Physics LLC.
Trial summary
The purpose of the study is to assess whether the addition of positron emission mammography will add diagnostic value to magnetic resonance imaging of the breast, in patients with lesions of the breast that are suspicious enough to warrant biopsy, or which have been confirmed as containing cancer cells. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MRI + PEM image
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 8 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female over 21 years of age;
- with a suspicious lesion found in the breast and recommended for biopsy or have a confirmed diagnosis of cancer;
- and in good health (other than having breast lesions);
- and can lie still in a prone position for 30 minutes in an MRI scanner.
Who cannot join
- Pregnancy;
- unwilling to give informed consent;
- have implanted prosthetic heart valve,
- pacemaker,
- neurostimulator,
- surgical clips or other metallic implants;
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- have engaged in occupations or received orthodontic work which may have caused lodging of ferromagnetic materials in the body;
- are claustrophobic;
- have been allergic to contrast agents;
- are diabetic;
- or have a history of kidney disease.
About this study
The purpose of the study is to assess whether the addition of positron emission mammography will add diagnostic value to magnetic resonance imaging of the breast, in patients with lesions of the breast that are suspicious enough to warrant biopsy, or which have been confirmed as containing cancer cells.
Read the detailed description
70 eligible subjects will be asked to undergo contrast-enhanced MRI studies of the breast containing the lesion. Subjects will be asked to fast for 6 hours prior to the imaging session. Each subject will be tested for glucose, and if the glucose is not too high, the subject will be injected with a dose of radioactive sugar (fluoro-deoxyglucose) which has been shown in other studies to accumulate in breast cancers. The subject will be asked to sit quietly for 30 minutes and to empty the bladder. The subject will then be asked to be re-examined in the MRI scanner with MRI contrast injection. The examination bed will be moved out of the MRI scanner and detectors of the radioactive sugar will be placed near the breast in order to obtain a positron emission mammogram for a 10-minute period. The subject will then leave the MRI suite.
- Conditions
- Breast Cancer
- Being tested
- MRI + PEM image
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI + PEM imageDevice
Also called flurodeoxyglucose
Effect of positron emission mammography on diagnostic accuracy
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic accuracy with MRI alone | No intervention | The MRI of the breast lesion will be examined. Measures of performance accuracy will be evaluated, including diagnostic sensitivity (true positives divided by true positives and false negatives), diagnostic specificity (true negatives divided by true negatives and false positives), and diagnostic accuracy, defined as the number of correct assessments divided by the number of all assessments. |
| Diagnostic accuracy with MRI + PEM image | Experimental | The combined PEM/MRI image will be examined. Receives: Device: MRI + PEM image |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of combination MRI/positron emission mammography (diagnostic accuracy, defined as the number of correct assessments divided by the number of all assessments)
Patients with benign disease on biopsy may be followed for up to 2 years after imaging
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study start1 Jul 2015
- Primary completion8 May 2016
- Study completion8 May 2016
Why it stopped: Subcontract PI left institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weinberg Medical Physics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Irvine
- Responsible party
- Sponsor
- Investigators
- Irving Weinberg, MD PhD, Principal investigator, Weinberg Medical Physics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426489
- Sponsor's protocol ID
- WMP-2
- Acronym
- MRI-PEM
- Status last verified
- Oct 2021
- First submitted
- 9 Apr 2015
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Diagnosis of Breast Cancer by Using a Combined MRI and Positron Emission Mammography (MRI-PEM) System
- ClinicalTrials.gov ID
- NCT02426489
- Acronym / sponsor ID
- MRI-PEM / WMP-2
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Subcontract PI left institution.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Weinberg Medical Physics LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of California, Irvine
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 8 May 2016 (actual)
- Study completion
- 8 May 2016 (actual)
- First posted
- 27 Apr 2015 (estimated)
- Results
- Not posted in the source record
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 the study is to assess whether the addition of positron emission mammography will add diagnostic value to magnetic resonance imaging of the breast, in patients with lesions of the breast that are suspicious enough to warrant biopsy, or which have been confirmed as containing cancer cells.
Detailed description
70 eligible subjects will be asked to undergo contrast-enhanced MRI studies of the breast containing the lesion. Subjects will be asked to fast for 6 hours prior to the imaging session. Each subject will be tested for glucose, and if the glucose is not too high, the subject will be injected with a dose of radioactive sugar (fluoro-deoxyglucose) which has been shown in other studies to accumulate in breast cancers. The subject will be asked to sit quietly for 30 minutes and to empty the bladder. The subject will then be asked to be re-examined in the MRI scanner with MRI contrast injection. The examination bed will be moved out of the MRI scanner and detectors of the radioactive sugar will be placed near the breast in order to obtain a positron emission mammogram for a 10-minute period. The subject will then leave the MRI suite.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diagnostic accuracy with MRI alone | No intervention | –The MRI of the breast lesion will be examined. Measures of performance accuracy will be evaluated, including diagnostic sensitivity (true positives divided by true positives and false negatives), diagnostic specificity (true negatives divided by true negatives and false positives), and diagnostic accuracy, defined as the number of correct assessments divided by the number of all assessments. |
| Diagnostic accuracy with MRI + PEM image | Experimental | Device: MRI + PEM imageThe combined PEM/MRI image will be examined. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female over 21 years of age;
- with a suspicious lesion found in the breast and recommended for biopsy or have a confirmed diagnosis of cancer;
- and in good health (other than having breast lesions);
- and can lie still in a prone position for 30 minutes in an MRI scanner.
Key exclusion criteria (11 listed)
- Pregnancy;
- unwilling to give informed consent;
- have implanted prosthetic heart valve,
- pacemaker,
- neurostimulator,
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 |
|---|---|---|
| MRI + PEM imageAlso: flurodeoxyglucoseEffect of positron emission mammography on diagnostic accuracy | Device | Diagnostic accuracy with MRI + PEM image |
Primary outcome
Diagnostic accuracy of combination MRI/positron emission mammography (diagnostic accuracy, defined as the number of correct assessments divided by the number of all assessments)
Time frame: up to 2 years
Patients with benign disease on biopsy may be followed for up to 2 years after imaging
Results and safety
The study was stopped early (reason given: Subcontract PI left institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Irving Weinberg, MD PhD principal investigator
Weinberg Medical Physics LLC
Questions about this trial
What is this clinical trial studying?
A study testing MRI + PEM image in people with Breast Cancer, run by Weinberg Medical Physics LLC.
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 11 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 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was stopped early (reason given: Subcontract PI left institution.). Results are not available in the source record.
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?
Diagnostic accuracy of combination MRI/positron emission mammography (diagnostic accuracy, defined as the number of correct assessments divided by the number of all assessments) (time frame: up to 2 years). 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 7 Oct 2021.