Breast Cancer Clinical Trial

Tomosynthesis vs. Contrast-Enhanced Mammography in Women With Personal History of Breast Cancer in Western Pennsylvania

Summary

This is a prospective clinical trial that will examine if contrast-enhanced mammography substantially improves breast cancer detection compared to mammography with tomosynthesis, with minimal increase in false-positives, in women with a personal history of breast cancer.

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Full Description

The investigators expect to show in a prospective clinical trial that, in women with a personal history of breast cancer, contrast-enhanced mammography substantially improves breast cancer detection compared to mammography with tomosynthesis, with minimal increase in false positives. The investigators expect a substantial increase in node-negative invasive cancers in particular. Because DBT will be interpreted first by one reader, and CEM will be interpreted first, and independently, by a second reader, there will also be an assessment of performance of tomosynthesis alone or CEM alone in this population. Participants will be invited to three rounds of annual screening with CEM. CEM must be performed at the time of or within 6 weeks of routine annual mammogram with tomosynthesis.

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Eligibility Criteria

Inclusion Criteria:

-Asymptomatic women, ages 30-85, with a personal history of breast cancer who have had at least one routine mammogram since treatment.

Exclusion Criteria:

Women with a history of prior iodinated contrast reaction
Women with implant(s) in the breasts to be screened (as this creates artifacts and diagnostic performance of imaging in women with implants likely does not generalize to those without implants, and the sample size with implants would be too small to infer conclusions)
Women who have had bilateral mastectomy
Women with a history of kidney failure or estimated glomerular filtration rate (eGFR) < 45 mL/min
Pregnancy or lactation
Women actively being treated for cancer of any type with chemotherapy
Lump or other breast symptoms
Abnormality on prior breast imaging that is being followed.

Study is for people with:

Breast Cancer

Estimated Enrollment:

1647

Study ID:

NCT04085510

Recruitment Status:

Active, not recruiting

Sponsor:

Wendie Berg

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There are 3 Locations for this study

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Magee Womancare Passavant Cranberry
Cranberry Township Pennsylvania, 16066, United States
Magee Womancare Monroeville
Monroeville Pennsylvania, 15146, United States
Magee Womens Hospital
Pittsburgh Pennsylvania, 15213, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

1647

Study ID:

NCT04085510

Recruitment Status:

Active, not recruiting

Sponsor:


Wendie Berg

How clear is this clinincal trial information?

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