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

Breast Cancer Clinical Trial

— TOCEM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04085510
• Other study ID #: STUDY19060359
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 23, 2019
• Est. completion date: June 30, 2027

Study information

• Verified date: January 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1647
• Est. completion date: June 30, 2027
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Female
• Breast Neoplasms
• Neoplasms

Intervention

Device:
• Contrast-enhanced mammogram
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.

Locations

Country	Name	City	State
United States	Magee Womancare Passavant Cranberry	Cranberry Township	Pennsylvania
United States	Magee Womancare Monroeville	Monroeville	Pennsylvania
United States	Magee Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Wendie Berg	Breast Cancer Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer Detection	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.	48 months
Secondary	Reader Validation	Reader validation will be performed at study conclusion: number of cancers detected with contrast-enhanced mammography or tomosynthesis.	48 months