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OpenTrials
Completed

NCT Number: NCT03517813

CESM ABMR Breast Cancer Screening Trial

This is a single institution, prospective screening trial of women at high risk for developing breast cancer, enriched with women with suspicious lesions on breast MRI which have been recommended for biopsy.

Primary Aim: Measure and compare the diagnostic performance of CESM, ABMR, and standard breast MRI, using the following performance measures: cancer detection rate (CDR), biopsy rate, and cancer yield of biopsy (also known as positive predictive value 3 or PPV3).

Secondary Aims:

1. Compare screening performance outcome measures of sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) for CESM, ABMR, and standard breast MRI. This will determine the feasibility of each modality as an alternative to standard breast MRI and provide valuable pilot data for designing a larger clinical trial to evaluate non-inferiority of either or both modalities. 2. Breast cancer characteristics (size, histologic subtype, node-positivity, AJCC stage) will be assessed in the overall cohort, and stratified by mode of detection for each modality(screen-detected versus interval).

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Key information

Conditions

Breast Cancer Screening

Age range

18 year–100 year

Sex eligibility

Female

Study type

Observational

Primary location

Seattle Cancer Care Alliance

Seattle, Washington, 98102, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures;
  • Women aged ≥18 years at the time of enrollment
  • Referred clinically for breast MRI for any indication

Exclusion criteria

  • Known allergy or contraindication to iodinated contrast
  • Are currently pregnant based on urine pregnancy test
  • Have breast implants
  • Are lactating

Treatment and study plan

Contrast-enhanced spectral mammography (CESM)

Device

Dual energy mammography images obtained after the administration of an intravenous contrast agent

Primary outcomes

  1. Abnormal interpretation rate

    Time frame: 2 years

    Abnormal interpretation rates for each modality (CESM, abbreviated breast MRI, standard breast MRI)

Secondary outcomes

  1. Biopsy rate

    Time frame: 2 years

    Biopsy rate will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)

  2. Positive predictive value for biopsy recommendation (PPV2)

    Time frame: 3 years

    Positive predictive value for biopsy recommendation (PPV2) will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)

  3. Negative predictive value

    Time frame: 3 years

    Negative predictive value will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)

  4. Cancer detection rate

    Time frame: 3 years

    Cancer detection rate will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)

  5. Sensitivity

    Time frame: 2 years

    Sensitivity will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)

  6. Specificity

    Time frame: 2 years

    Specificity will be assessed for each modality (CESM, abbreviated breast MRI, standard breast MRI)

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • GE Healthcare

Registry information

Official study title

Comparative Performance of Contrast-enhanced Spectral Mammography (CESM) and Abbreviated Breast MRI (ABMR) With Standard Breast MRI for Breast Cancer Screening

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
May 7, 2018
Registry last updated
Jan 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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