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NCT Number: NCT04085510

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

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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This study is active but is not currently recruiting participants.

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Key information

Age range

30 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Magee Womancare Passavant Cranberry, Cranberry Township, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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) < 30 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.

Treatment and study plan

Contrast-enhanced mammogram

Device

Contrast-enhanced mammography (CEM) is a new FDA-approved exam that is similar to magnetic resonance imaging (MRI) in depicting breast cancers due to increased and leaky blood vessels. Contrast-enhanced mammography is used as an adjunct following mammography and/or ultrasound examinations to localize a known or suspected lesion.

Primary outcomes

  1. Cancer Detection

    Time frame: 48 months

    Number of participants with cancer detected with contrast-enhanced mammography compared to tomosynthesis. Number of patients recalled for additional testing by each imaging test who do not have cancer (false positives). Outcomes will be assessed for both prevalence and incidence screens.

Secondary outcomes

  1. Reader Validation

    Time frame: 48 months

    Reader validation will be performed at study conclusion: number of cancers detected with contrast-enhanced mammography or tomosynthesis.

Sponsors and collaborators

Lead sponsor

Wendie Berg

Other

Collaborators

  • Breast Cancer Research Foundation

Registry information

Official study title

Improving Surveillance of Women With Personal History of Breast Cancer Using Contrast-Enhanced Mammography (CEM)

Acronym: TOCEM

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
Sep 11, 2019
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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