The C-MERIT Screening Cohort: Contrast-enhanced Mammography for Breast Cancer Screening and Risk Assessment in Women With Dense Breasts

The C-MERIT Screening Cohort: Contrast-enhanced Mammography for Breast Cancer Screening and Risk Assessment in Women With Dense Breasts
warning 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

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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

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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
Resource links provided by the National Library of Medicine NIH NLM ABRV BLK 4

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Contrast Enhanced Mammography Diagnostic Test: Contrast Enhanced Mammography

Screening Modality

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Primary Outcome Measures :

  1. To identify female MDACC patients with dense breasts who undergo contrast-enhanced mammography [ Time Frame: through study completion; an average of 1 year. ]

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

MD Anderson Cancer Center

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)

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT05667532    
Other Study ID Numbers: 2022-0651
NCI-2022-10200 ( Other Identifier: NCI-CTRP Clinical Trials Registry )
First Posted: December 28, 2022    Key Record Dates
Last Update Posted: December 29, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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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.

December 30, 2022Comments OffClinicalTrials.gov | Oncology Clinical Trials | Oncology Studies | US National Library of Medicine
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