Comparison of Positron Emission Mammography and Contrast-enhanced Breast MRI

NCT02770586 | Completed

• 1 other identifier: 15-004872
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield of breast cancers detected on PEM compared to MRI

  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

Study Arms (1)

Breast PET

OTHER

Breast PET

Diagnostic Test: Breast PET

Interventions

Breast PET DIAGNOSTIC_TEST

imaging of the breast using the Breast PET system

Breast PET

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Michael O'Connor, PHD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: May 12, 2016
• Study Start: August 1, 2015
• Primary Completion: June 11, 2019
• Study Completion: October 12, 2019
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)