Trial Outcomes & Findings for Contrast-Enhanced Mammography for Breast Cancer Staging in Patients Referred for a Second Opinion (NCT NCT05036083)
NCT ID: NCT05036083
Last Updated: 2025-09-17
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
89 participants
Primary outcome timeframe
One timepoint (at presentation) for lesion characterization with 24 month follow-up for outcome data collection
Results posted on
2025-09-17
Participant Flow
Eligible and interested subjects will be consented for study participation. A research staff member who is trained in the informed consent process will explain the study, invite the patients to enroll, and obtain the informed consent of women who wish to participate. Subjects may be enrolled using the approved MD Anderson procedures for remote consenting.
Participant milestones
| Measure |
Contrast Enhanced Mammography for Breast Cancer Staging in Patients Referred for Second Opinion
* Female patients with known invasive or in-situ breast cancer diagnosed at an outside facility and presenting to MD Anderson for staging with imaging.
* Female patients referred from outside institutions with imaging findings categorized as highly suspicious (BI-RADS 5 or 4C) on outside imaging or on re-review by MD Anderson's radiologists, and referred for staging at MDACC.
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|---|---|
|
Overall Study
STARTED
|
89
|
|
Overall Study
COMPLETED
|
83
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Contrast Enhanced Mammography for Breast Cancer Staging in Patients Referred for Second Opinion
* Female patients with known invasive or in-situ breast cancer diagnosed at an outside facility and presenting to MD Anderson for staging with imaging.
* Female patients referred from outside institutions with imaging findings categorized as highly suspicious (BI-RADS 5 or 4C) on outside imaging or on re-review by MD Anderson's radiologists, and referred for staging at MDACC.
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|---|---|
|
Overall Study
Physician Decision
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1
|
|
Overall Study
Withdrawal by Subject
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1
|
|
Overall Study
Labs outside instition parameter, eGFR
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3
|
|
Overall Study
IV not sustainable
|
1
|
Baseline Characteristics
Contrast-Enhanced Mammography for Breast Cancer Staging in Patients Referred for a Second Opinion
Baseline characteristics by cohort
| Measure |
Contrast Enhanced Mammography for Breast Cancer Staging in Patients Referred for Second Opinion
n=89 Participants
* Female patients with known invasive or in-situ breast cancer diagnosed at an outside facility and presenting to MD Anderson for staging with imaging.
* Female patients referred from outside institutions with imaging findings categorized as highly suspicious (BI-RADS 5 or 4C) on outside imaging or on re-review by MD Anderson's radiologists, and referred for staging at MDACC.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
66 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
23 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
72 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
89 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: One timepoint (at presentation) for lesion characterization with 24 month follow-up for outcome data collectionRate 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
Outcome measures
| Measure |
Contrast Enhanced Mammography for Breast Cancer Staging in Patients Referred for Second Opinion
n=164 Total number of lesions
* Female patients with known invasive or in-situ breast cancer diagnosed at an outside facility and presenting to MD Anderson for staging with imaging.
* Female patients referred from outside institutions with imaging findings categorized as highly suspicious (BI-RADS 5 or 4C) on outside imaging or on re-review by MD Anderson's radiologists, and referred for staging at MDACC.
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|---|---|
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Accuracy of CEM for Incremental Cancer Detection in the Ipsilateral and Contralateral Breasts.
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41.4 % of malignancy in new CEM lesions
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SECONDARY outcome
Timeframe: At presentation, Day 1Fraction of malignant lesions detected by each component of CEM
Outcome measures
| Measure |
Contrast Enhanced Mammography for Breast Cancer Staging in Patients Referred for Second Opinion
n=164 Total number of lesions
* Female patients with known invasive or in-situ breast cancer diagnosed at an outside facility and presenting to MD Anderson for staging with imaging.
* Female patients referred from outside institutions with imaging findings categorized as highly suspicious (BI-RADS 5 or 4C) on outside imaging or on re-review by MD Anderson's radiologists, and referred for staging at MDACC.
|
|---|---|
|
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.
Total number of detected lesions (index and non-index)
|
164 lesions
|
|
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.
Malignant index and non-index lesions
|
126 lesions
|
|
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.
Benign index and non-index lesions
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32 lesions
|
|
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.
High-risk lesions
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6 lesions
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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.
RC-only detected malignant lesions
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20 lesions
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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.
LE+RC detected malignant lesions
|
103 lesions
|
|
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.
LE-only detected malignanct lesions
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3 lesions
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SECONDARY outcome
Timeframe: One timepoint- at presentationLargest 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.
Outcome measures
| Measure |
Contrast Enhanced Mammography for Breast Cancer Staging in Patients Referred for Second Opinion
n=164 Total number of lesions
* Female patients with known invasive or in-situ breast cancer diagnosed at an outside facility and presenting to MD Anderson for staging with imaging.
* Female patients referred from outside institutions with imaging findings categorized as highly suspicious (BI-RADS 5 or 4C) on outside imaging or on re-review by MD Anderson's radiologists, and referred for staging at MDACC.
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|---|---|
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Percentage of Lesions That Appeared Larger on CEM
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28 % of malignant lesions larger on CEM
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SECONDARY outcome
Timeframe: 1 timepoint at presentationPopulation: Patients who had additional malignant lesions detected as a result of CEM work-up
Percentage of patients with a change in the number of cancers sites (unifocal, multifocal, or bilateral) compared to outside facility imaging interpretation
Outcome measures
| Measure |
Contrast Enhanced Mammography for Breast Cancer Staging in Patients Referred for Second Opinion
n=83 Participants
* Female patients with known invasive or in-situ breast cancer diagnosed at an outside facility and presenting to MD Anderson for staging with imaging.
* Female patients referred from outside institutions with imaging findings categorized as highly suspicious (BI-RADS 5 or 4C) on outside imaging or on re-review by MD Anderson's radiologists, and referred for staging at MDACC.
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|---|---|
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Incremental Cancer Detection Rate Provided by CEM, DBT and US Compared to Outside Imaging
Patients with unifocal cancer as detected at outside imaging
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68 Participants
|
|
Incremental Cancer Detection Rate Provided by CEM, DBT and US Compared to Outside Imaging
Patients with unifocal cancer after MDACC work-up
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50 Participants
|
|
Incremental Cancer Detection Rate Provided by CEM, DBT and US Compared to Outside Imaging
Patients with unknown staging as presented at outside imaging
|
3 Participants
|
|
Incremental Cancer Detection Rate Provided by CEM, DBT and US Compared to Outside Imaging
Patients with unknown staging after MDACC work-up
|
0 Participants
|
|
Incremental Cancer Detection Rate Provided by CEM, DBT and US Compared to Outside Imaging
Mutlicentric/miultifocal cancer as detected at outside imaging
|
11 Participants
|
|
Incremental Cancer Detection Rate Provided by CEM, DBT and US Compared to Outside Imaging
Mutlicentric/miultifocal cancer after MDACC work-up
|
27 Participants
|
|
Incremental Cancer Detection Rate Provided by CEM, DBT and US Compared to Outside Imaging
Patients with bilateral cancer at outside imaging
|
1 Participants
|
|
Incremental Cancer Detection Rate Provided by CEM, DBT and US Compared to Outside Imaging
Patients with bilateral cancer after MDACC work-up
|
6 Participants
|
SECONDARY outcome
Timeframe: One timepoint (at presentation) for lesion characterisation with 24 mo follow-up for outcome data collectionRate of RC-only detected malignancy, LE+RC detected malignancy, LE-only detected malignancy
Outcome measures
| Measure |
Contrast Enhanced Mammography for Breast Cancer Staging in Patients Referred for Second Opinion
n=164 Total number of lesions
* Female patients with known invasive or in-situ breast cancer diagnosed at an outside facility and presenting to MD Anderson for staging with imaging.
* Female patients referred from outside institutions with imaging findings categorized as highly suspicious (BI-RADS 5 or 4C) on outside imaging or on re-review by MD Anderson's radiologists, and referred for staging at MDACC.
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|---|---|
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Rate of Malignancy
Rate of RC-only detected malignancy (%)
|
16 percentage of malignancy
|
|
Rate of Malignancy
Rate of LE+RC detected malignancy (%)
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82 percentage of malignancy
|
|
Rate of Malignancy
Rate of LE-only detected malignancy (%)
|
8 percentage of malignancy
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One timepoint for CEM data (at presentation) +/- 2 month (4 month total) for MRIPopulation: Study patients who underwent both breast MRI and CEM. The fraction of the patients with MRI prompting a change in management
Percentage of patients who underwent both CEM and MRI
Outcome measures
| Measure |
Contrast Enhanced Mammography for Breast Cancer Staging in Patients Referred for Second Opinion
n=83 Participants
* Female patients with known invasive or in-situ breast cancer diagnosed at an outside facility and presenting to MD Anderson for staging with imaging.
* Female patients referred from outside institutions with imaging findings categorized as highly suspicious (BI-RADS 5 or 4C) on outside imaging or on re-review by MD Anderson's radiologists, and referred for staging at MDACC.
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|---|---|
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Rate of Breast MRI Utilization and the Corresponding Diagnosis in the Study Cohort.
Patients with breast MRI
|
33 Participants
|
|
Rate of Breast MRI Utilization and the Corresponding Diagnosis in the Study Cohort.
MRI changed management
|
20 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Contrast Enhanced Mammography for Breast Cancer Staging in Patients Referred for Second Opinion
n=53 Lesions
* Female patients with known invasive or in-situ breast cancer diagnosed at an outside facility and presenting to MD Anderson for staging with imaging.
* Female patients referred from outside institutions with imaging findings categorized as highly suspicious (BI-RADS 5 or 4C) on outside imaging or on re-review by MD Anderson's radiologists, and referred for staging at MDACC.
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|---|---|
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The Fraction of CEM Biopsies That Achieve Adequate Sampling of the Target.
Fraction of non-index lesions recommended for a CEM-guided biopsy (%)
|
15 percentage of successful CEM biopsies
|
|
The Fraction of CEM Biopsies That Achieve Adequate Sampling of the Target.
Fraction of successful CEM-guided biopsies (%)
|
100 percentage of successful CEM biopsies
|
Adverse Events
Contrast Enhanced Mammography for Breast Cancer Staging in Patients Referred for Second Opinion
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Contrast Enhanced Mammography for Breast Cancer Staging in Patients Referred for Second Opinion
n=89 participants at risk
* Female patients with known invasive or in-situ breast cancer diagnosed at an outside facility and presenting to MD Anderson for staging with imaging.
* Female patients referred from outside institutions with imaging findings categorized as highly suspicious (BI-RADS 5 or 4C) on outside imaging or on re-review by MD Anderson's radiologists, and referred for staging at MDACC.
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|---|---|
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General disorders
Saline flush extravasation
|
1.1%
1/89 • At presentation, Day 1
|
|
Gastrointestinal disorders
Mild nausea
|
1.1%
1/89 • At presentation, Day 1
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place