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Biennial CEM in Women With a Personal History of Breast Cancer

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
30 Years to 79 Years
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding a mammogram with contrast dye every two years to yearly 3D mammograms helps find more breast cancers with few extra false alarms. It is for women ages 30–79 who have had breast cancer and have no symptoms.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women ages 30–79 who have had breast cancer and have no symptoms.
  • At least one year has passed since breast cancer surgery and/or treatment.
  • Scheduled for a routine yearly 3D mammogram.

Who can't join

  • Past moderate or severe reaction to iodine-based contrast dye. A mild reaction is allowed only if medicines can control it and you strongly want to join. If you have a mild reaction and are allergic to Benadryl, you cannot join.
  • Breast implants in the breasts being screened, or surgery to remove both breasts.
  • Past kidney failure or an eGFR below 30 mL/min—a test result showing how well your kidneys filter blood.
  • Pregnant or breastfeeding.
  • Currently getting chemotherapy for any cancer.
  • Stage 4 cancer that has spread to internal organs or the brain.
  • A screening breast MRI within 24 months before the current contrast mammogram.
  • A mammogram with contrast dye within the past 23 months.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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) \< 30 mL/min * Pregnancy or lactation * Women actively being treated for cancer of any type with chemotherapy. * Women with stage 4 metastasis to visceral areas or brain * Women with known personal history of breast cancer who have a screening breast MRI exam within 24 months prior to the current round of CEM. * Women with known personal history of breast cancer who had a CEM exam within the prior 23 months

Study sites (6)

PA