Can contrast enhanced spectral mammography (CESM) play a clinically useful role in the pre-operative assessment of women with Ductal Carcinoma in Situ (DCIS), the ‘CESM D’ study

Not Applicable

Recruiting

• Conditions: Ductal Carcinoma in Situ; Cancer - Breast

• Registration Number: ACTRN12616001696482
• Lead Sponsor: Clin. Assoc. Prof. Donna Taylor

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

a. Able to give written informed consent
b. Women with one or more pure ductal carcinoma in situ (DCIS) lesion(s) on core biopsy
c. Women who are over the ages of 18 at diagnosis
d. Women undergoing assessment at Royal Perth Hospital, WA

Exclusion Criteria

a. Inability to give written informed consent (women whose English comprehension is such that they are considered unable to give informed consent will be excluded)
b. Evidence of invasive disease within the subject focus of DCIS
c. Women who decline or are unfit to have breast surgery
d. Women who are pregnant or lactating.
e. Contraindications for CESM including
i. Previous reaction to contrast media or allergic reaction requiring medical attention
ii. Known renal disease (including renal transplant)
iii. Diabetes Mellitus (including any patient taking metformin)
iv. Poorly controlled asthma
v. Known or suspected thyrotoxicosis
vi. Patients who are to undergo diagnostic or therapeutic procedures involving radioisotope scanning of the thyroid within 8 weeks of CESM.
vii. Known Myasthenia graves
viii. Previous administration of IV contrast within 24hours
f. Presence of breast implants
g. Limited mobility such that the CESM study cannot be completed within 10 minutes of contrast injection

Study & Design

• Study Type: Interventional
• Study Design: Not specified