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Not yet recruiting NCT06993246

Contrast-enhanced Mammography in Women With a Personal History of Breast Cancer and Dense Breast Tissue: Benefit?

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Contrast-Enhanced Mammography (CEM).
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 50 years — 69 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Does Supplemental Contrast-enhanced Mammography Have a Benefit in Women With a Personal History of Breast Cancer and Dense Breast Tissue? A Prospective Cohort Study.

Overview

This study aims to assess the effectiveness of Contrast-Enhanced Mammography (CEM)as an alternative to traditional ultrasound for breast cancer screening in women with dense breasts and a personal history of breast cancer. CEM combines standard mammography with a contrast agent to better detect tumors, particularly in women with dense tissue where traditional mammograms may miss signs of cancer. The study will compare CEM with ultrasound and MRI to determine its accuracy in detecting cancer, reduce wait times for screening, and provide a more affordable option than MRI. Women who participate will have their screening done in one visit, improving convenience and access. The study will track cancer detection rates, biopsy results, and patient satisfaction over two years to evaluate the benefits of CEM for early breast cancer detection.

Detailed description

Primary Outcome Measure: 1. Detection Rate of Breast Cancer The primary outcome measure is the detection rate of breast cancer in women with dense breast tissue using contrast-enhanced mammography (CEM). The sensitivity, specificity, and overall accuracy of CEM in detecting malignancies will be compared to conventional mammography and ultrasound.

Interventions

  • Diagnostic test Contrast-Enhanced Mammography (CEM)
    The intervention involves the use of contrast-enhanced mammography (CEM) to supplement standard mammography for breast cancer screening. This method utilizes iodinated contrast medium to enhance the visualization of breast lesions by assessing tumor neovascularization. CEM will be offered to women with dense breast tissue who are currently awaiting supplemental ultrasound screening. It is designed to be performed in conjunction with regular mammography, offering a more efficient and cost-effecti

Primary outcome measures

  • Detection Rate of Breast Cancer [Time frame: Three years from the study start date.]
Secondary outcome measures (2)
  • Lesion Characterization [Time frame: Up to one year.]
  • Patient Experience [Time frame: Immediate post-procedure.]

Eligibility criteria

Inclusion criteria

  • Women presenting at Rose Ages Breast Health Center, who are currently waiting for supplemental screening Ultrasound, according to pre-established guidelines at TOH for supplemental screening.
  • Women ages 50-69 years of age
  • Those willing to participate in the study, sign an informed consent and undergo IV iodinated contrast injection
  • Women with dense breasts (category C or D) and normal mammograms (BI-RADS 1 or 2)
  • No evidence of renal disease

Exclusion criteria

  • Patients with renal insufficiency (reduced eGFR <20ml/min)
  • Previous allergic reactions to Iodine-based contrast.
  • Prior contrast allergy (CT contrast)
  • Thyroid Disease

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Canada · 1 center
  • The Ottawa Hospital — Ottawa

Identifiers

NCT: NCT06993246 · OHSN- REB 20240828-01H

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗