Comparison of Positron Emission Mammography and Contrast-enhanced Breast MRI (PEM/MRI)

May 8, 2023 updated by: Mayo Clinic

Comparison of Positron Emission Mammography and Contrast-enhanced Breast MRI in Women With a High Suspicion of Breast Cancer

The hypothesis of this study is that positron emission mammography will provide comparable sensitivity to contrast-enhanced breast MRI in women with a high suspicion of breast cancer.

The aim of this study is to determine the sensitivity of Positron Emission Mammography (PEM) relative to that of Contrast-enhanced breast MRI (CE-MRI) in women with a high suspicion of breast cancer

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study Overview:

The study population will comprise 150 women with a BI-RAD 5 or 6 finding on recent imaging who are scheduled for contrast enhanced breast MRI. Recruitment will be from the pool of patients scheduled for an MRI in the Department of Radiology at Mayo Clinic Rochester. All patients will have a PEM study within 5 business days of the clinically indicated MRI. Subjects must meet the following eligibility criteria:

  1. Recent imaging study (mammogram, tomosynthesis, MBI or ultrasound) interpreted as highly suggestive of malignancy or a known biopsy proven malignancy [Breast Imaging Reporting and Data System (BI-RADS) Category 5 or 6]
  2. Scheduled to undergo or has recently undergone a contrast-enhanced breast MRI
  3. Age 25 or older

The interpretation will be performed by different study radiologists blinded to the results of the other study. Prior breast imaging studies (mammography, tomosynthesis, MBI and ultrasound) and medical record will be available to the interpreting physician. Following the separate interpretations, an integrated interpretation of the MRI and PEM images will be performed to match any lesions seen and determine final clinical management of the patient.

Reference standard will be surgical pathology or biopsy. For findings that were not resolved through biopsy or surgery, follow up data, including any imaging and / or biopsies performed in the 365 day period following study entry (date of the study PEM) will be collected through medical record review (and patient interview for those who do not return for further clinical management).

The primary analysis is to compare the PEM diagnostic yield to the MRI diagnostic yield, which is considered the standard for this trial. The primary analysis will use the observed MRI diagnostic yield as the control value.

If the 95% Confidence Interval (CI) for the PEM diagnostic yield lies entirely below the MRI diagnostic yield value, PEM will be deemed inferior to MRI for detecting breast cancer in this patient population. If the 95% CI for the PEM diagnostic yield contains the MRI diagnostic yield value, PEM will be deemed equivalent to MRI for detecting breast cancer.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All women in this study will have recent imaging study (mammogram, tomosynthesis, MBI or ultrasound) interpreted as highly suspicious for malignancy or known biopsy-proven malignancy (BI-RADS Category 5 or 6 within 60 days prior to the MRI or PEM study
  • Scheduled or will be scheduled for clinically indicated contrast-enhanced breast MRI examination
  • PEM must be performed within 5 business days, prior to or following the clinical MRI
  • Participant has signed the study-specific informed consent prior to registration
  • Age 25 or older

Exclusion Criteria:

  • Unable to understand and sign the consent form
  • Pregnant or lactating
  • Physically unable to lie prone for ~20 minutes
  • Undergone bilateral mastectomy
  • Weight more than 300 lbs (weight limit on PEM table)
  • Have contraindications to the clinical MRI examination
  • Scheduled to undergo breast biopsy or surgery in the time period between the PEM and MRI studies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Breast PET
Diagnostic test: Breast PET
imaging of the breast using the Breast PET system

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diagnostic yield of breast cancers detected on PEM compared to MRI
Time Frame: One week
The primary analysis is to compare the PEM diagnostic yield to the MRI diagnostic yield, which is considered the standard for this trial. The primary analysis will use the observed MRI diagnostic yield as the control value. The diagnostic yield of PEM will be estimated with a binomial point estimate and corresponding 95% binomial confidence interval (CI). The point estimate for the diagnostic yield (for both MRI and PEM) will be the number of confirmed breast cancers detected by the imaging (i.e. as determined by the reference standard) divided by the number of eligible and evaluable patients.
One week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael O'Connor, PHD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 11, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 12, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15-004872

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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