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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05667532 |
|
Recruitment Status : **RECRUITING NOW**
First Posted : December 28, 2022 Last Update Posted : December 29, 2022 |
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
Brief 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
| Breast Cancer | Diagnostic Test: Contrast Enhanced Mammography |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 1000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | The C-MERIT Screening Cohort: Contrast-enhanced Mammography for Breast Cancer Screening and Risk Assessment in Women With Dense Breasts |
| Actual Study Start Date : | December 5, 2022 |
| Estimated Primary Completion Date : | December 31, 2026 |
| Estimated Study Completion Date : | December 31, 2027 |
| Contrast Enhanced Mammography | Diagnostic Test: Contrast Enhanced Mammography
Screening Modality |
- To identify female MDACC patients with dense breasts who undergo contrast-enhanced mammography [ Time Frame: through study completion; an average of 1 year. ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study:  | 30 Years to 75 Years  (Adult, Older Adult) |
| Sexes Eligible for Study: Â | Female |
| Accepts Healthy Volunteers: Â | No |
| Sampling Method: Â | Non-Probability Sample |
MD Anderson Cancer Center
Inclusion Criteria:
- 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
- Willingness to co-enroll or currently enrolled in PA17-0584
- Willingness to participate in the study and ability to provide informed consent
Exclusion Criteria:
- Self-reported new breast symptoms since last mammogram including nipple discharge, palpable mass, skin dimpling, or focal pain.
- Current or recent (within the prior 6 months) history of pregnancy or breast feeding
- Personal history of breast cancer (DCIS or invasive breast cancer)
- Treatment of any other type of cancer within the past 5 years excluding in-situ cervical and non-melanoma skin cancer
- Breast biopsy within 6 months
- Breast surgery within 12 months
- Breast MRI, MBI, or CEM performed within 24 months
- Known allergy to iodine-containing contrast agents
- 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
- Renal insufficiency (as defined by UTMDACC policy 3.30- attachment 1 (appendix D)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05667532
| M D Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Contact: Olena Weaver, MD   713-745-4555   ooweaver@mdanderson.org   | |
| Principal Investigator: Olena Weaver, MD Â Â Â Â Â Â | |
M.D. Anderson Cancer Center
| Principal Investigator: | Olena Weaver, MD | M.D. Anderson Cancer Center |
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT05667532 Â Â |
| Other Study ID Numbers: | 2022-0651 NCI-2022-10200 ( Other Identifier: NCI-CTRP Clinical Trials Registry ) |
| First Posted: | December 28, 2022 Â Â Key Record Dates |
| Last Update Posted: | December 29, 2022 |
| Last Verified: | December 2022 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
| Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
