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Trial Title:
The C-MERIT Screening Cohort: Contrast-enhanced Mammography for Breast Cancer Screening and Risk Assessment in Women With Dense Breasts
NCT ID:
NCT05667532
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Contrast Enhanced Mammography
Description:
Screening Modality
Arm group label:
Contrast Enhanced Mammography
Summary:
To learn whether a new imaging technology, Contrast-Enhanced Mammography (CEM), compared
to standard mammography, can better detect breast cancers in women with dense breasts
Detailed description:
Primary Objectives:
- To establish a cohort of 1,000 female MDACC patients with dense breasts who undergo
screening contrast-enhanced mammography.
- To establish a comprehensive integrated database of imaging, clinical data, health
measurements, and questionnaire data including data from the companion protocol
PA17-0584.
Secondary Objectives:
- To perform within-subject comparison of the cancer detection rate between CEM and
FFDM.
- To perform within-subject comparison of the sensitivity, specificity, and recall
rates of CEM compared to low-energy (LE) images (FFDM equivalent) and compared to a
combination of LE and DBT images among women with dense breasts.
- To evaluate the effect of the availability of prior imaging for comparison on the
recall rates of CEM, FFDM and DBT.
- In patients who undergo screening breast ultrasound as a standard of care, to
evaluate the performance of screening ultrasound for breast cancer detection and
compare it with other imaging modalities of CEM, LE images, and DBT.
Exploratory Objectives:
- To combine imaging, blood biomarkers, health measurements and questionnaire data for
assessment of breast cancer risk.
- To evaluate if the intensity of background parenchymal enhancement on CEM predicts
breast cancer risk in women with dense breasts.
- To evaluate if patients consider CEM as a potentially acceptable imaging modality
for routine breast cancer screening.
Criteria for eligibility:
Study pop:
MD Anderson Cancer Center
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Female patients 30-75 years of age with dense breasts (ACR BI-RADS categories C and
D) who undergo routine yearly mammography at participating MDACC sites
2. Willingness to co-enroll or currently enrolled in PA17-0584
3. Willingness to participate in the study and ability to provide informed consent
Exclusion Criteria:
1. Self-reported new breast symptoms since last mammogram including nipple discharge,
palpable mass, skin dimpling, or focal pain.
2. Current or recent (within the prior 6 months) history of pregnancy or breast feeding
3. Personal history of breast cancer (DCIS or invasive breast cancer)
4. Treatment of any other type of cancer within the past 5 years excluding in-situ
cervical and non-melanoma skin cancer
5. Breast biopsy within 6 months
6. Breast surgery within 12 months
7. Breast MRI, MBI, or CEM performed within 24 months
8. Known allergy to iodine-containing contrast agents
9. History of anaphylactic reaction to any substance that required hospitalization or
IV placement in a patient with no known prior uneventful exposure to iodine-based IV
contrast
10. Renal insufficiency (as defined by UTMDACC policy 3.30- attachment 1 (appendix D)
Gender:
Female
Minimum age:
30 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Olena Weaver, MD
Phone:
713-745-4555
Email:
ooweaver@mdanderson.org
Investigator:
Last name:
Olena Weaver, MD
Email:
Principal Investigator
Start date:
December 5, 2022
Completion date:
December 31, 2027
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05667532
http://www.mdanderson.org
