Health TrialsbyHealthPanel

Biennial CEM in Women With a Personal History of Breast Cancer

ConditionsBreast CancerBreast NeoplasmsBreast Cancer FemaleNeoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-79
SponsorWendie Berg

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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) < 30 mL/min

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

1,600 Participants
are divided into 1 treatment group
Group A: contrast-enhanced mammographyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incremental Cancer Detection Rate

CEM cancer detection rate for first observer vs usual care (annual DBT)

Time frame
at 24 months, 48 months, and 62 months
2

False-positive recall rate

CEM false-positive findings for first observer vs usual care (annual DBT)

Time frame
at 24 months, 48 months, and 62 months
3

Positive-predictive values

CEM positive-predictive values for first observer vs usual care (annual DBT)

Time frame
at 24 months, 48 months, and 62 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wendie Berg

Lead sponsor

University of Pittsburgh

Sponsor institution

Breast Cancer Research Foundation

Collaborator

Source ClinicalTrials.gov
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