Can Contrast Enhanced Spectral Mammography (CESM) Reduce the Number of Benign Biopsies for Calcifications Without Negatively Impacting on Detection/Diagnosis of Clinically Significant Calcifications

Last updated: February 26, 2019
Sponsor: The Leeds Teaching Hospitals NHS Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Scleroderma

Treatment

N/A

Clinical Study ID

NCT03857152
RD17/91109
  • Ages 50-70
  • Female

Study Summary

Women who attend for their screening mammogram will be recalled if an abnormality is detected on the screening mammogram. Calcifications account for 20% of the women recalled to second stage screening. Currently there is no effective imaging tool to determine if the calcifications are cancer or not. Therefore, 90% of women will be subjected to a biopsy. 25-30% of the biopsies will show cancer. Contrast enhanced spectral mammography (CESM) is where contrast is given and then a mammogram performed. The theory is that high risk DCIS and invasive cancers have an increased blood supply and will therefore enhance more than benign lesions within the breast. If CESM can identify calcifications that are cancerous then we maybe able to reduce the number of women who have benign biopsies. This is patient focused as women would not require a biopsy and be able to be reassured at the same visit. This is also a cost-saving for the Trust by reducing unnecessary biopsies. This also supports the findings of the Marmot review by aiming to reduce harm by over-diagnosis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Recalled for second stage screening due to microcalcifications on the mammogram

  2. Renal function is within normal limits

  3. No known allergies to contrast

  4. Able to give informed consent

Exclusion

Exclusion Criteria:

  1. Known allergy to contrast

  2. Renal impairment

  3. Unable to provide informed consent

  4. Having radioactive iodine treatment for hyperthyroidism

Study Design

Total Participants: 250
Study Start date:
December 03, 2018
Estimated Completion Date:
February 02, 2021

Connect with a study center

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS1 3HE,
    United Kingdom

    Active - Recruiting

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