Comparative evaluation of Contrast Enhanced Spectral Mammography (CESM) and Contrast Enhanced Magnetic Resonance Imaging (CEMRI) for local staging of breast cancer: the CESM V study

Not Applicable

• Conditions: ocal staging of primary breast cancer; Local staging of primary breast cancer; Cancer - Breast

• Registration Number: ACTRN12613000684729
• Lead Sponsor: Royal Perth Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Female of any race or ethnicity.
-Aged 35 years and over.
-Core biopsy proven diagnosis of invasive breast cancer in one or both breasts.
-Participant fit to undergo surgical treatment, either breast conservation surgery or mastectomy.

Exclusion Criteria

-Male.
-Unable or unwilling to give informed consent.
-Impaired mobility (good mobility is needed to ensure the CESM can be performed within the required time after the contrast injection is given).
-Presence of breast implants.
-Pregnancy or breast feeding.
-A participant who is not fit for or declines surgical treatment.
-participant who is going to have neoadjuvant chemotherapy
-The breast lesion consists solely of in-situ” carcinoma on core biopsy histology.
-Contraindication to the intravenous use of iodinated or gadolinium-chelated contrast agent, particularly renal insufficiency or allergy.
-Known contraindication to MRI examination, e.g. metallic implant, aneurysm clip

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of additional lesions (each classified as benign or suspicious, to allow determination of TP, FP, TN, FN).<br>[Time points for assessment of primary outcome: immediately after the CESM and CEMRI studies have been performed, at time results of any core biopsies of these lesions (within 2-3 weeks of the studies), or at time of definitive surgery with review of pathology (usually within 6-8 weeks of diagnosis), or for those lesions not biopsied or excised, review with imaging follow up one year post diagnosis.]

Secondary Outcome Measures

Name	Time	Method
Size of the index malignant lesion(s)[Immediately following the CESM and MRI studies when they are reported by the radiologist.];times taken for the CESM or CEMRI procedure [measured at time of these procedures];times taken by radiologists to read the studies[measured at time radiologist fills in the CRF with the results of their assessment of the CESM or CEMRI examination];Participants will be asked to complete a brief satisfaction survey using a Likert scale and a free text comment [Filled in just after they have had their second of the two tests, which depending on the bookings will be the CESM or the CEMRI examination]