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

  • STATUS
    Recruiting
  • End date
    Mar 28, 2026
  • participants needed
    1650
  • sponsor
    Wendie Berg
Updated on 7 October 2022
cancer
breast cancer
primary cancer
mammogram
tomosynthesis
Accepts healthy volunteers

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.

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.

Details
Condition Breast Cancer Female, Breast Cancer, Breast Neoplasms, Neoplasms
Treatment Contrast-enhanced mammogram
Clinical Study IdentifierNCT04085510
SponsorWendie Berg
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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 who have had bilateral mastectomy
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
Pregnancy or lactation
those without implants, and the sample size with implants would be too small to infer
conclusions)
Lump or other breast symptoms
Women actively being treated for cancer of any type with chemotherapy
Abnormality on prior breast imaging that is being followed
Women with a history of kidney failure or estimated glomerular filtration rate (eGFR)
< 45 mL/min
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