Biennial CEM in Women With a Personal History of Breast Cancer

Part of paid clinical trials in Bethel Park, Pennsylvania.

Sponsor
Wendie Berg
Study ID
NCT06105749
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
30 Years - 79 Years
Healthy Volunteers
Accepted

Interventions

  • contrast-enhanced mammography — 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.

Study Details

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.

Key Dates

Start date
Nov 8, 2023
Status verified
Sep 2025
Primary completion
Dec 31, 2029
Completion
Apr 30, 2031

Study Design

Enrollment
1,500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: contrast-enhanced mammography
    Enrolled participants will receive a baseline contrast-enhanced mammography exam for breast cancer screening, along with their scheduled 3D mammography exam, then they will receive another CEM exam for breast cancer screening at 24 months after their baseline CEM exam, and then again at 48 months. All the while, participants will still receive their annual 3D mammography exam as per their usual routine care.

Primary Outcome Measure

Incremental Cancer Detection Rate [ Time Frame: at 24 months, 48 months, and 62 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
UPMC Magee-Womens Imaging - Bethel ParkBethel ParkPennsylvania15102
McKenna Rigling, MS
[email protected]
412-641-8278
Maegan Johnson, RN
[email protected]
412-641-8283
Wendie Berg, MD, PhD (PRINCIPAL_INVESTIGATOR)
UPMC Magee at the Lemieux Sports ComplexCranberry TownshipPennsylvania16066
McKenna Rigling, MS
[email protected]
412-641-8278
Maegan Johnson, RN
[email protected]
412-641-8283
Wendie Berg, MD, PhD (PRINCIPAL_INVESTIGATOR)
Magee Womancare MonroevilleMonroevillePennsylvania15146
McKenna Rigling, MS
[email protected]
412-641-8278
Maegan Johnson, RN
[email protected]
412-641-8283
Wendie Berg, MD, PhD (PRINCIPAL_INVESTIGATOR)
Hillman Cancer Center at ShadysidePittsburghPennsylvania15232
McKenna Rigling, MS
[email protected]
412-641-8278
Maegan Johnson, RN
[email protected]
412-641-8283
Wendie Berg, MD, PhD (PRINCIPAL_INVESTIGATOR)
Magee-Womens HospitalPittsburghPennsylvania15213
McKenna Rigling, MS
[email protected]
412-641-8278
Maegan Johnson, RN
[email protected]
412-641-8283
Wendie Berg, MD, PhD (PRINCIPAL_INVESTIGATOR)
UPMC West Mifflin Outpatient CenterWest MifflinPennsylvania15236
McKenna Rigling, MS
[email protected]
412-941-8278
Maegan Johnson, RN
[email protected]
412-641-8283
Wendie Berg, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Bethel Park, PA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
UPMC Magee-Womens Imaging - Bethel Park· Bethel Park, PAUPMC Magee at the Lemieux Sports Complex· Cranberry Township, PAMagee Womancare Monroeville· Monroeville, PAHillman Cancer Center at Shadyside· Pittsburgh, PAMagee-Womens Hospital· Pittsburgh, PAUPMC West Mifflin Outpatient Center· West Mifflin, PA

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