Contrast-Enhanced Mammography for Breast Cancer Staging in Patients Referred for a Second Opinion
Added Value of Contrast Enhanced Mammography for Breast Cancer Staging in Patients Referred for a Second Opinion to a Tertiary Cancer Center
Study Overview
Status
Conditions
Detailed Description
PRIMARY OBJECTIVE:
I. To compare the accuracy of CEM and low energy (LE) images (equivalent of full field digital mammogram [FFDM] as the standard of care) for the detection of additional cancer sites in the affected breast and in the contralateral breast.
SECONDARY OBJECTIVES:
I. To evaluate the sensitivity, specificity, positive and negative predictive value of CEM compared to LE CEM images (FFDM equivalent), digital breast tomosynthesis (DBT) and ultrasound for the detection of additional malignant lesions in the ipsilateral and contralateral breast.
II. To evaluate the difference of the index cancer size estimation among CEM, LE images, DBT, and ultrasound compared to pathology measurements as the ground truth.
III. To evaluate the incremental cancer detection rate provided by CEM, DBT, and ultrasound (US) compared to the outside facility (OSF) diagnosis.
EXPLORATORY OBJECTIVES:
I. To evaluate the rate of referral to breast magnetic resonance imaging (MRI) in the study cohort.
II. To evaluate the performance of MRI for breast cancer diagnosis and compare it with other imaging modalities of CEM, LE images, DBT, and US.
III. To evaluate the feasibility of CEM-guided biopsy of CEM-only detected lesions.
OUTLINE:
Patient receive iodinated contrast agent intravenously (IV) and undergo CEM. Patients who have not undergone DBT as part of their screening or diagnostic imaging within 3 month, undergo DBT. Patients medical records are reviewed.
After completion of study treatment, patients are followed up for 12 months.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Texas
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Houston, Texas, United States, 77030
- M D Anderson Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female patients 18 years of age or older with known invasive or in-situ breast cancer (BC) diagnosed at an outside facility and presenting to MD Anderson for staging with imaging
- Female patients 18 years of age or older referred from outside institutions with imaging findings categorized as highly suspicious (Breast Imaging Reporting and Data System [BI-RADS] 5 or 4C) on outside imaging or on rereview by MD Anderson's radiologists and referred for staging at MD Anderson Cancer Center (MDACC)
- Willingness to participate in the study and ability to provide informed consent
Exclusion Criteria:
- Breast surgery within 6 months
- Known allergy to iodine-containing contrast agents
- History of anaphylactic reaction to any substance that required hospitalization or IV placement
- Renal insufficiency; hyperthyroidism
- Detection of non-breast primary or metastatic cancer in the breast
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diagnostic (CEM, DBT, medical record)
Patient receive iodinated contrast agent IV and undergo CEM.
Patients who have not undergone DBT as part of their screening or diagnostic imaging within 3 month, undergo DBT.
Patients medical records are reviewed.
|
Medical records reviewed
Undergo CEM
Other Names:
Undergo DBT
Other Names:
Given IV
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Accuracy of CEM for Incremental Cancer Detection in the Ipsilateral and Contralateral Breasts.
Time Frame: One timepoint (at presentation) for lesion characterization with 24 month follow-up for outcome data collection
|
Rate of malignancy in lesions de-novo detected on CEM at MDACC and not detected on outside facility imaging. New non-index lesions detected on CEM that had a benign/malignant outcome on image-guided biopsy, surgery, or had a 24-month imaging follow-up with no cancer development (lesion-level evaluation) *Index lesion was defined as follows: A) Known cancer detected at an outside facility B) Highly suspicious imaging lesion detected at an outside facility, for which a consultation was requested |
One timepoint (at presentation) for lesion characterization with 24 month follow-up for outcome data collection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensitivity, Specificity, Positive and Negative Predictive Value of CEM: RC (Recombined Images) and LE (Low Energy) Images, DBT (Digital Breast Tomosynthesis), and Ultrasound Compared to Pathology as the Ground Truth.
Time Frame: At presentation, Day 1
|
Fraction of malignant lesions detected by each component of CEM
|
At presentation, Day 1
|
|
Percentage of Lesions That Appeared Larger on CEM
Time Frame: One timepoint- at presentation
|
Largest measurements in imaging were compared to the largest measurements in pathology and the size difference of 5mm or more was considered significant.
Fraction of patients in whom CEM detected an increase in lesion size of 5 mm or more was reported and analyzed.
|
One timepoint- at presentation
|
|
Incremental Cancer Detection Rate Provided by CEM, DBT and US Compared to Outside Imaging
Time Frame: 1 timepoint at presentation
|
Percentage of patients with a change in the number of cancers sites (unifocal, multifocal, or bilateral) compared to outside facility imaging interpretation
|
1 timepoint at presentation
|
|
Rate of Malignancy
Time Frame: One timepoint (at presentation) for lesion characterisation with 24 mo follow-up for outcome data collection
|
Rate of RC-only detected malignancy, LE+RC detected malignancy, LE-only detected malignancy
|
One timepoint (at presentation) for lesion characterisation with 24 mo follow-up for outcome data collection
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Breast MRI Utilization and the Corresponding Diagnosis in the Study Cohort.
Time Frame: One timepoint for CEM data (at presentation) +/- 2 month (4 month total) for MRI
|
Percentage of patients who underwent both CEM and MRI
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One timepoint for CEM data (at presentation) +/- 2 month (4 month total) for MRI
|
|
The Fraction of CEM Biopsies That Achieve Adequate Sampling of the Target.
Time Frame: Two timepoints- at first CEM imaging presentation and at CEM-guided biopsy (within 2 months)
|
Patients who required a CEM-guided biopsy and successfully underwent it with adequate tissue sampling.
Percentage of all non-index CEM lesions that required a CEM biopsy.
|
Two timepoints- at first CEM imaging presentation and at CEM-guided biopsy (within 2 months)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Olena Weaver, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-1267 (Other Identifier: M D Anderson Cancer Center)
- NCI-2021-08979 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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