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

Wendie Berg

Status: Active, not recruiting

Conditions: Breast Cancer; Breast Cancer Female; Neoplasms; Breast Neoplasms

Treatments: Device: Contrast-enhanced mammogram

Study type: Interventional

Funder types: Other

Identifiers

NCT04085510

STUDY19060359

Details and patient eligibility

About

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.

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.

Enrollment: 1,647 patients

Sex: Female

Ages: 30 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,647 participants in 1 patient group

Contrast-enhanced mammogram

Experimental group

Description:

All women will receive both 3D mammography and contrast-enhanced mammography for breast cancer screening; the order of interpretation will vary for each of two radiologists

Treatment:

Device: Contrast-enhanced mammogram