Biennial CEM in Women With a Personal History of Breast Cancer

Breast Cancer Clinical Trial

Official title:

Outcome of Biennial Screening Contrast-Enhanced Mammography (CEM) in Women With a Personal History of Breast Cancer (PHBC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06105749
• Other study ID #: STUDY23080183
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2023
• Est. completion date: April 2031

Study information

• Verified date: November 2023
• Source: University of Pittsburgh
• Contact: Wendie Berg, MD, PhD
• Phone: 412-641-8278
• Email: bergwa[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective clinical trial that will examine if biennial contrast-enhanced mammography added to annual 3D mammography (tomosynthesis) substantially improves breast cancer detection with minimal increase in false-positives, in women with a personal history of breast cancer.

Description:

The investigators seek to determine if improved breast cancer detection is maintained with biennial contrast-enhanced mammography (CEM) added to annual digital breast tomosynthesis (DBT) with overall fewer false positives than from annual DBT plus CEM. The investigators will offer biennial CEM exams for eligible patients. Enrolled participants will have a baseline CEM exam with their routine DBT exam, and then have another CEM exam 24 months after their baseline CEM exam and then again at 48 months. Participants will continue to have their annual DBT exams during this time as a part of their usual care. Two radiologists (one primary) will evaluate each pair of examinations by sequentially interpreting each of DBT and CEM in opposing order (primary reader DBT then CEM and secondary reader CEM then DBT), initially blinded to the other modality. We expect that with biennial screening, at least a similar number of cancers will be detected with CEM (and possibly more that were occult on the DBT-only screen 12 months prior), with a similar incremental false-positive rate and at least similar (if not improved) overall positive predictive value (PPV1).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: April 2031
• Est. primary completion date: December 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 79 Years

Eligibility

Inclusion Criteria:

• Asymptomatic women, ages 30-79, with a personal history of breast cancer who are at least one year out from any breast cancer surgery and/or treatment and are scheduled to have a routine annual mammogram with tomosynthesis (DBT).

Exclusion Criteria:

• Women with a history of prior moderate or severe iodinated contrast reaction [only those with a prior mild reaction that can be managed by pre-medication AND with and a strong desire to participate will be allowed to participate. However, among these women with a mild sensitivity, if they are allergic to Benadryl (one of the premedications), they will be excluded].
• 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
• Having only one kidney
• Women with stage 4 metastasis to visceral areas or brain
• Women who have a screening breast MRI exam within 24 months prior to the current round of CEM.
• Women who had a CEM exam within the prior 23 months

Related Conditions & MeSH terms

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

Intervention

Device:
• contrast-enhanced mammography
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	UPMC Magee-Womens Imaging - Bethel Park	Bethel Park	Pennsylvania
United States	UPMC Magee at the Lemieux Sports Complex	Cranberry Township	Pennsylvania
United States	Magee Womancare Monroeville	Monroeville	Pennsylvania
United States	Magee-Womens Hospital	Pittsburgh	Pennsylvania
United States	UPMC West Mifflin Outpatient Center	West Mifflin	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	Incremental Cancer Detection Rate	CEM cancer detection rate for first observer vs usual care (annual DBT)	at 24 months, 48 months, and 62 months
Primary	False-positive recall rate	CEM false-positive findings for first observer vs usual care (annual DBT)	at 24 months, 48 months, and 62 months
Primary	Positive-predictive values	CEM positive-predictive values for first observer vs usual care (annual DBT)	at 24 months, 48 months, and 62 months